ClearanceBrief
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)
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Top companies in DSI

DateFirm and productCodeLinked 510(k)
May 1, 2026Spacelabs 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
DSIK103142
Apr 7, 2026Spacelabs Healthcare, Inc.
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Open, Classified
DSIK103142
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX800. Product Number: 865240.
Open, Classified
DSIK150310
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX700. Product Number: 865241.
Open, Classified
DSIK150310
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX600. Product Number: 865242.
Open, Classified
DSIK150310
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX450. Product Number: 866062.
Open, Classified
DSIK130849
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX400. Product Number: 866060.
Open, Classified
DSIK130849
Dec 2, 2025Philips North America Llc
IntelliVue Patient Monitor MX100. Product Number: 867033.
Open, Classified
DSIK171801
Dec 2, 2025Philips North America Llc
IntelliVue Multi-Measurement Module X3. Product Number: 867030.
Open, Classified
DSIK171801
Dec 2, 2025Philips North America Llc
IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Open, Classified
DSIK150310
Dec 2, 2025Philips North America Llc
IntelliVue MP90. Product Number: M8010A.
Open, Classified
DSIK151681
Dec 2, 2025Philips North America Llc
IntelliVue MP80. Product Number: M8008A.
Open, Classified
DSIK151681
Dec 2, 2025Philips North America Llc
IntelliVue MP70. Product Number: M8007A.
Open, Classified
DSIK151681
Dec 2, 2025Philips North America Llc
IntelliVue MP60. Product Number: M8005A.
Open, Classified
DSIK151681
Dec 2, 2025Philips North America Llc
IntelliVue MP50. Product Number: M8004A.
Open, Classified
DSIK151681
Dec 2, 2025Philips North America Llc
IntelliVue MP40. Product Number: M8003A.
Open, Classified
DSIK151681
Dec 2, 2025Philips North America Llc
IntelliVue MP30. Product Number: M8002A.
Open, Classified
DSIK122439
Dec 2, 2025Philips North America Llc
IntelliVue MP20. Product Number: M8001A.
Open, Classified
DSIK122439
Dec 2, 2025Philips North America Llc
IntelliVue MP5. Product Number: M8105A.
Open, Classified
DSIK150310
Dec 2, 2025Philips North America Llc
IntelliVue MP2. Product Number: M8102A.
Open, Classified
DSIK150310
Jun 10, 2025GE 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
DSIK992637
Oct 8, 2024Philips 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
DSIK113125
K153702
Oct 1, 2024Philips North America
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Open, Classified
DSIK151681
May 3, 2023Spacelabs Healthcare, Inc.
Ultraview SL (UVSL) Command Module, Model 91496
Open, Classified
DSIK103142
Nov 4, 2022iRhythm 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
DSIK163512
Feb 2, 2021Philips 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
DSIK113125
Nov 18, 2020Philips 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
DSIK083517
Nov 18, 2020Philips 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
DSIK082633
Jun 8, 2020Philips 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
DSIK993383
Nov 12, 2019GE 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
DSIK133882
Nov 12, 2019GE 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
DSIK032370
K053356 +1
Nov 12, 2019GE 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
DSIK000779
K021325 +3
Oct 23, 2019GE 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
DSIK000779
K021325 +3
Aug 6, 2019Preventice 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
DSIK151188
Mar 28, 2019Philips 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
DSIK113125
Mar 28, 2019Philips 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
DSIK113125
Mar 28, 2019Philips 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
DSIK113125
Mar 28, 2019Philips 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
DSIK113125
Oct 10, 2018Philips 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
DSIK113125
Apr 30, 2018Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
Terminated
DSIK113125
Apr 30, 2018Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
Terminated
DSIK113125
Apr 30, 2018Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
Terminated
DSIK113125
Apr 30, 2018Philips Electronics North America Corporation
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
Terminated
DSIK113125
Mar 6, 2017Philips 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
DSIK113125
Aug 4, 2016Spacelabs 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
DSIK103142
Feb 25, 2016Scottcare 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
DSIK092947
Feb 23, 2016Medtronic Inc.
Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
Terminated
DSIK132649
May 4, 2015Spacelabs 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
DSIK103142
Apr 28, 2015Spacelabs 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
DSIK103142
Jun 3, 2014Spacelabs 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
DSIK103142

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