Panels › Cardiovascular › Product code DSI · Class 2
Detector And Alarm, Arrhythmia
Regulation 870.1025
1510(k)s in 12 months (398 all time)
20recalls in 12 months (82 all time)
78recalls that name a 510(k)
Top companies in DSI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2026 | Spacelabs Healthcare, Inc. Brand Name: Spacelabs Ultraview SL Command Module
Product Name: SL Command Module
Model/Catalog Number: 91496
Software Version: N/A
Product Description: The Command Module (91496) is the core of the S Open, Classified |
DSI | K103142 |
| Apr 7, 2026 | Spacelabs Healthcare, Inc. Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor Open, Classified |
DSI | K103142 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX800. Product Number: 865240. Open, Classified |
DSI | K150310 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX700. Product Number: 865241. Open, Classified |
DSI | K150310 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX600. Product Number: 865242. Open, Classified |
DSI | K150310 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX450. Product Number: 866062. Open, Classified |
DSI | K130849 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX400. Product Number: 866060. Open, Classified |
DSI | K130849 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Patient Monitor MX100. Product Number: 867033. Open, Classified |
DSI | K171801 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Multi-Measurement Module X3. Product Number: 867030. Open, Classified |
DSI | K171801 |
| Dec 2, 2025 | Philips North America Llc IntelliVue Multi Measurement Server X2. Product Number: M3002A. Open, Classified |
DSI | K150310 |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP90. Product Number: M8010A. Open, Classified |
DSI | K151681 |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP80. Product Number: M8008A. Open, Classified |
DSI | K151681 |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP70. Product Number: M8007A. Open, Classified |
DSI | K151681 |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP60. Product Number: M8005A. Open, Classified |
DSI | K151681 |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP50. Product Number: M8004A. Open, Classified |
DSI | K151681 |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP40. Product Number: M8003A. Open, Classified |
DSI | K151681 |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP30. Product Number: M8002A. Open, Classified |
DSI | K122439 |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP20. Product Number: M8001A. Open, Classified |
DSI | K122439 |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP5. Product Number: M8105A. Open, Classified |
DSI | K150310 |
| Dec 2, 2025 | Philips North America Llc IntelliVue MP2. Product Number: M8102A. Open, Classified |
DSI | K150310 |
| Jun 10, 2025 | GE Medical Systems Information Technologies Inc MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information. Open, Classified |
DSI | K992637 |
| Oct 8, 2024 | Philips North America Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1 Open, Classified |
DSI | K113125 K153702 |
| Oct 1, 2024 | Philips North America IntelliVue G7m Anesthesia Gas Module, Product Number 866173 Open, Classified |
DSI | K151681 |
| May 3, 2023 | Spacelabs Healthcare, Inc. Ultraview SL (UVSL) Command Module, Model 91496 Open, Classified |
DSI | K103142 |
| Nov 4, 2022 | iRhythm Technologies, Inc. Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system Open, Classified |
DSI | K163512 |
| Feb 2, 2021 | Philips North America Llc IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple Terminated |
DSI | K113125 |
| Nov 18, 2020 | Philips North America Llc Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neo Terminated |
DSI | K083517 |
| Nov 18, 2020 | Philips North America Llc Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pedi Terminated |
DSI | K082633 |
| Jun 8, 2020 | Philips North America, LLC Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036) Terminated |
DSI | K993383 |
| Nov 12, 2019 | GE Healthcare, LLC CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central St Terminated |
DSI | K133882 |
| Nov 12, 2019 | GE Healthcare, LLC CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospit Terminated |
DSI | K032370 K053356 +1 |
| Nov 12, 2019 | GE Healthcare, LLC ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and mon Terminated |
DSI | K000779 K021325 +3 |
| Oct 23, 2019 | GE Healthcare, LLC ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care a Open, Classified |
DSI | K000779 K021325 +3 |
| Aug 6, 2019 | Preventice Services, LLC BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the mon Terminated |
DSI | K151188 |
| Mar 28, 2019 | Philips North America, LLC IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All:
453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the Open, Classified |
DSI | K113125 |
| Mar 28, 2019 | Philips North America, LLC IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371
Product Usage: Used primarily as a t Open, Classified |
DSI | K113125 |
| Mar 28, 2019 | Philips North America, LLC IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers
All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467 Open, Classified |
DSI | K113125 |
| Mar 28, 2019 | Philips North America, LLC IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the Intel Open, Classified |
DSI | K113125 |
| Oct 10, 2018 | Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological par Open, Classified |
DSI | K113125 |
| Apr 30, 2018 | Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146 Terminated |
DSI | K113125 |
| Apr 30, 2018 | Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352 Terminated |
DSI | K113125 |
| Apr 30, 2018 | Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351 Terminated |
DSI | K113125 |
| Apr 30, 2018 | Philips Electronics North America Corporation IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350 Terminated |
DSI | K113125 |
| Mar 6, 2017 | Philips Electronics North America Corporation Philips IntelliVue MX4O WLAN Patient Wearable Monitor
Product: 865352
Exchange part (service numbers):
453564615311 TELE PWM,802.lla/b/g,ECG only, US only
453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, Terminated |
DSI | K113125 |
| Aug 4, 2016 | Spacelabs Healthcare Inc 91496 Ultraview SL Command Module, Options A, B, C, and I.
Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP.
Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 Terminated |
DSI | K103142 |
| Feb 25, 2016 | Scottcare Corporation TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation.
Terminated |
DSI | K092947 |
| Feb 23, 2016 | Medtronic Inc. Reveal LINQ insertable Cardiac Monitor, Model LNQ11.
Monitors subcutaneous ECG continuously. Terminated |
DSI | K132649 |
| May 4, 2015 | Spacelabs Healthcare Inc Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02.
The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acqu Terminated |
DSI | K103142 |
| Apr 28, 2015 | Spacelabs Healthcare Inc Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option.
Product Usage:
The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PC Terminated |
DSI | K103142 |
| Jun 3, 2014 | Spacelabs Healthcare Inc Spacelabs Medical Ultraview SL Command Module, Model 91496.
Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and Terminated |
DSI | K103142 |
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