Panels › Cardiovascular › Product code MWI · Class 2
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation 870.2300
6510(k)s in 12 months (309 all time)
11recalls in 12 months (85 all time)
80recalls that name a 510(k)
Top companies in MWI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2014 | Invivo Corporation Philips Expression MR200 MRI Patient Monitoring System Terminated |
MWI | K131382 |
| Oct 8, 2014 | Mckesson Information Solutions LLC McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. Terminated |
MWI | K131497 |
| Oct 1, 2014 | Invivo Corporation Philips Expression MR200 MRI Patient Monitoring System Model 866120 Terminated |
MWI | K131382 |
| Sep 14, 2014 | Invivo Corporation Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 Terminated |
MWI | K121424 |
| Aug 19, 2014 | Invivo Corporation Philips IP5 Information Portal
The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care pr Terminated |
MWI | K121424 |
| Aug 14, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box.
The Vital Sync Virtua Terminated |
MWI | K130796 K132604 +1 |
| Aug 14, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box.
The Vital Sync Virtual Pat Terminated |
MWI | K130796 K132604 +1 |
| Feb 26, 2014 | Invivo Corporation Invivo Corporation Expression IP5 Information Portal
Product Usage:
The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is int Terminated |
MWI | K121424 |
| Feb 14, 2014 | Invivo Corporation Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI proced Terminated |
MWI | K121424 |
| Jan 23, 2014 | Medrad Mr Inc Medrad Veris MR Monitor units
The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made ava Terminated |
MWI | K042569 |
| Jan 7, 2014 | Welch Allyn Protocol, Inc The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN.
These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for Terminated |
MWI | K033378 |
| Jul 29, 2013 | Sotera Wireless, Inc. ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parame Terminated |
MWI | K112478 K122036 |
| Jul 29, 2013 | Sotera Wireless, Inc. ViSi Mobile Monitor, Catalog No. 92-10010
The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of Terminated |
MWI | K112478 K122036 |
| Jun 25, 2013 | Medrad Inc DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor:
Product Usage:
Monitor, Physiological, Patient Terminated |
MWI | K042569 |
| Feb 14, 2013 | Viterion TeleHealthcare Llc Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms).
Viterion V100, V100-BGM and V5 Terminated |
MWI | K004050 |
| Feb 14, 2013 | Viterion TeleHealthcare Llc Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) .
Viterion V100, V100-BGM and V500 Telehealth Terminated |
MWI | K030419 |
| Feb 14, 2013 | Viterion TeleHealthcare Llc Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Terminated |
MWI | K030419 |
| Jan 27, 2013 | Mindray DS USA, Inc. d.b.a. Mindray North America Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities. Terminated |
MWI | K053234 |
| Dec 4, 2012 | Invivo Corporation Invivo Corporation Expression MRI Patient Monitoring System.
The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoin Terminated |
MWI | K090785 |
| Sep 13, 2012 | Capsule Tech Inc. Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System
Catalog Number DC-NU-DS-CK
The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. T Terminated |
MWI | K013019 K020197 +2 |
| Feb 15, 2012 | Viterion TeleHealthcare Llc Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer H Terminated |
MWI | None listed |
| Oct 27, 2011 | Invivo Corporation Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits).
Label located on the back of the WPU. Product is labeled in part: "***In Terminated |
MWI | K053462 |
| Oct 25, 2011 | Invivo Corporation "***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564 Terminated |
MWI | K090785 |
| Jun 1, 2011 | Capsule Tech Inc. Capsule Neuron UMPC is a component in the DataCaptor" Connectivity System.
Catalog Number: DC-NU-MPC
Capsule Neuron" UMPC is a bedside device that enables automatic collection of vital signs data th Terminated |
MWI | K013019 K020197 +1 |
| May 11, 2011 | Remote Diagnostic Technologies Ltd. TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT.
Indicated for 3 Lead ECG mo Terminated |
MWI | K101264 |
| Apr 8, 2010 | Philips Healthcare Inc. DeviceLink Connectivity Hardware.
Supports Philips specified manufacturers' devices including urimeters, ventilators, oximeters, patient monitors, infusion pumps and anesthesia machines. Terminated |
MWI | K051134 |
| Jul 30, 2009 | Welch Allyn Protocol, Inc Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300).
The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units co Terminated |
MWI | K053027 K063419 |
| Feb 6, 2009 | Invivo Corporation 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826
These rechargeab Terminated |
MWI | K053462 K063559 |
| Jul 23, 2007 | Smiths Medical PM, Inc. BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200) Terminated |
MWI | K010770 K030407 +1 |
| Dec 15, 2006 | Medrad Inc Veris Invasive Blood Pressure Interface Cables-Part # 3010478. The product is an accessory to patient physiological monitor. Terminated |
MWI | K042569 |
| Dec 15, 2006 | Medrad Inc Invasive Blood Pressure Interface Cables: a)
Medrad 9500 Multigas monitor for MRI, Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Bloo Terminated |
MWI | K983250 |
| Nov 28, 2006 | Welch Allyn Protocol, Inc Propaq LT vital signs monitor, Model 802LTRN Terminated |
MWI | K033378 |
| Nov 28, 2006 | Welch Allyn Protocol, Inc Propaq LT vital signs monitor, Model 802LTON Terminated |
MWI | K033378 |
| Dec 23, 2005 | Witt Biomedical Corporation Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053. Terminated |
MWI | K033030 |
| Oct 15, 2003 | GE Medical Systems Information Technologies Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Me Terminated |
MWI | K012915 K020022 +1 |
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