Panels › Cardiovascular › Product code MHX · Class 2
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation 870.1025
16510(k)s in 12 months (431 all time)
41recalls in 12 months (294 all time)
277recalls that name a 510(k)
Top companies in MHX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2025 | Baxter Healthcare Corporation Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers:
1) 73WT-B;
2) 74CE-B;
3) 74CT-B;
4) 74CX-B;
5) 74ME-B;
6) 74MT-B;
7) 74MX-B;
8) 74RE-B;
9) 74RT-B;
10) 75CE-B;
11) Open, Classified |
MHX | K171621 |
| Apr 14, 2025 | Baxter Healthcare Corporation Welch Allyn Connex Vital Signs Monitor (CVSM): Open, Classified |
MHX | K171621 |
| Feb 5, 2025 | Philips North America Llc IntelliVue Patient Monitor MX550. Model Number: 866066 Open, Classified |
MHX | K082583 |
| Feb 5, 2025 | Philips North America Llc IntelliVue Patient Monitor MX500. Model Number: 866064 Open, Classified |
MHX | K082583 |
| Feb 5, 2025 | Philips North America Llc IntelliVue Patient Monitor MX450. Model Number: 866062 Open, Classified |
MHX | K082583 |
| Feb 5, 2025 | Philips North America Llc IntelliVue Patient Monitor MX400. Model Number: 866060 Open, Classified |
MHX | K082583 |
| Feb 5, 2025 | Philips North America Llc IntelliBridge EC10 Module. Model Number: 865115 Open, Classified |
MHX | K082583 |
| Jan 30, 2025 | Draeger Medical Systems, Inc. Infinity Central Station. Model Number: MS26800
The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical Open, Classified |
MHX | K151860 |
| Jan 7, 2025 | Spacelabs Healthcare, Inc. Xhibit Telemetry Receiver, Model 96280, with Service Manual.
Intended to provide monitoring system with patient data. Open, Classified |
MHX | K141156 |
| Jan 7, 2025 | Spacelabs Healthcare, Inc. Xhibit Telemetry Receiver with Software, Model 96280.
Intended to provide monitoring system with patient data. Open, Classified |
MHX | K141156 |
| Dec 17, 2024 | Philips North America Llc Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 Open, Classified |
MHX | None listed |
| Oct 4, 2024 | Philips North America Llc IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows:
1) IntelliVue MX400 866060;
2) IntelliVue MX450 866062;
3) Open, Classified |
MHX | K130849 K131872 |
| Sep 30, 2024 | Philips North America Llc DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central
monitoring system.
Model: RGD2461AMI
Philips Part # 866126 Open, Classified |
MHX | K153702 |
| Sep 25, 2024 | Philips North America IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066) Open, Classified |
MHX | K130849 K131872 |
| Aug 5, 2024 | Philips North America Llc IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements
Model Number: 866066.
Indicated for use by health care professionals for monitoring and recording of, and to gene Open, Classified |
MHX | K130849 |
| Aug 5, 2024 | Philips North America Llc IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements
Model Number: 866064.
Indicated for use by health care professionals for monitoring and recording of, and to gene Open, Classified |
MHX | K130849 |
| Aug 5, 2024 | Philips North America Llc IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements
Model Number: 866062.
Indicated for use by health care professionals for monitoring and recording of, and to gen Open, Classified |
MHX | K130849 |
| Aug 5, 2024 | Philips North America Llc IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements
Model Number: 866060.
Indicated for use by health care professionals for monitoring and recording of, and to gene Open, Classified |
MHX | K130849 |
| Jun 25, 2024 | Draeger Medical Systems, Inc. Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23 Open, Classified |
MHX | K203088 |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE B850 Model Numbers:
a) MBC303, Model Numbers:
1) 2078633-001,
2) 2078633-010,
3) 2078633-012,
4) 2078633-017,
5) 2078633-028,
6) 2095802-001-54069330,
7) 2095802-001-554922,
8) 2 Open, Classified |
MHX | K191149 K213181 |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE B650: Model Numbers:
a) MBB313, Model Numbers:
1) 2095801-001,
2) 2095801-001-01018416,
3) 2095801-001-01023150,
4) 2095801-001-01023151,
5) 2095801-001-01023152,
6) 2095801-001-01 Open, Classified |
MHX | K191149 K213181 |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE Canvas Smart Display, Model Numbers:
a) 5514418,
b) 5514418 / MAEP2,
c) 5514418-01059642,
d) 5514418-01080402,
e) 5514418-01081317,
f) 5514418-01086007,
g) 5514418-01086838,
h) 55 Open, Classified |
MHX | K191323 K213336 |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE Canvas Smart Display, Model Numbers:
a) 5700023,
b) 5700023-02,
c) 5939590-102;
monitor, physiological, patient Open, Classified |
MHX | K223531 |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE Canvas 1000, Model Numbers:
a) 5865770;
b) 5865770-01040169;
c) 5865770-01054142;
d) 5865770-01054696;
e) 5865770-01054698;
f) 5865770-01054721;
g) 5865770-01054740;
h) 5865770-0105 Open, Classified |
MHX | K223531 |
| Jun 6, 2024 | Nihon Kohden America Inc BSM-3000 Series Bedside Monitor REF BSM-3572A
The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs Open, Classified |
MHX | None listed |
| May 15, 2024 | Philips North America Llc Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. Open, Classified |
MHX | K153702 |
| Apr 25, 2024 | Philips North America Llc Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS):
1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply
Model: SCL500RM1U
2. APC (Schneider Elec Open, Classified |
MHX | K153702 |
| Mar 27, 2024 | Philips North America Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X Open, Classified |
MHX | K153702 |
| Jan 13, 2024 | Philips North America (1) CareEvent, Model No. 866435
(2) CareEvent Upgrade, Model no. 866436 Open, Classified |
MHX | K153702 K161164 |
| Jan 13, 2024 | Philips North America (1) Patient Information Center iX, Model No. 866389
(2) Patient Information Center iX Expand, Model No. 866390
(3) PIC iX Hardware, Model No. 866424 Open, Classified |
MHX | K153702 K161164 |
| Sep 29, 2023 | GE Medical Systems China Co., Ltd. F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) Open, Classified |
MHX | K223531 |
| Sep 21, 2023 | Remote Diagnostic Technologies Ltd. Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044 Open, Classified |
MHX | K201746 |
| Sep 19, 2023 | Philips North America Llc Patient Information Center iX with Software Version Number 4.x in the following:
(1) Patient Information Center iX Product Number: 866389;
(2) Patient Information Center iX Expand Product Number: 8 Open, Classified |
MHX | K153702 |
| Apr 27, 2023 | Draeger Medical Systems, Inc. Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity pat Open, Classified |
MHX | K200859 |
| Apr 27, 2023 | Draeger Medical Systems, Inc. Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower Open, Classified |
MHX | K151860 |
| Apr 1, 2023 | Remote Diagnostic Technologies Ltd. Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital Open, Classified |
MHX | K201746 |
| Dec 19, 2022 | GE Medical Systems, LLC B125M Patient Monitor, REF 6160000-005-XXXXXXX Open, Classified |
MHX | K213490 |
| Dec 19, 2022 | GE Medical Systems, LLC B125M Patient Monitor, REF 6160000-004-XXXXXX Open, Classified |
MHX | K213490 |
| Dec 19, 2022 | GE Medical Systems, LLC B105M Patient Monitor, REF 6160000-003 Open, Classified |
MHX | K213490 |
| Dec 19, 2022 | GE Medical Systems, LLC B125P Patient Monitor (with E-module slot option), REF 6160000-002 Open, Classified |
MHX | K213490 |
| Dec 19, 2022 | GE Medical Systems, LLC B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX, Open, Classified |
MHX | K213490 |
| May 31, 2022 | Spacelabs Healthcare, Inc. Xhibit Telemetry Receiver, Model: 96280 Open, Classified |
MHX | K141156 |
| Mar 4, 2022 | Draegar Medical Systems, Inc. Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices. Open, Classified |
MHX | K130711 |
| Jul 23, 2021 | GE Healthcare, LLC CARESCAPE PDM-Masimo SpO2. Physiological data monitor. Open, Classified |
MHX | K071073 |
| May 25, 2021 | Remote Diagnostic Technologies Ltd. Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm.
Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a t Open, Classified |
MHX | K201746 |
| Mar 23, 2021 | Philips North America, LLC Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare envir Terminated |
MHX | K123900 |
| Feb 10, 2021 | Draegar Medical Systems, Inc. Infinity Acute Care System (IACS) Monitoring Solution:
The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient Open, Classified |
MHX | K093788 K113798 |
| Aug 4, 2020 | GE Healthcare, LLC CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple Terminated |
MHX | K200494 |
| Jun 30, 2020 | Philips North America, LLC IntelliVue MX700 patient monitor, model no. 865241 Terminated |
MHX | K150310 |
| Jun 30, 2020 | Philips North America, LLC IntelliVue MX800 patient monitor, model no. 865240 Terminated |
MHX | K150310 |
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