Peerbridge Cor(TM) System

510(k) Number

K171936 ↗

FDA product code

DSH

Device class

Class II

Regulation

21 CFR Part 870.2800

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code DSH (Recorder, Magnetic Tape, Medical).

• ZIO PATCH, MODEL Z100 by IRHYTHM TECHNOLOGIES, INC.
• SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION by Spacelabs, Inc.
• LIFEPAK 5 MONITOR, CASSETTE, #800923-01 by PHYSIO-CONTROL, Inc.
• MYPATCH by dms-service, LLC
• HOLTER KIT MODEL #5000 SERIES by Conmed Andover Medical, Inc.
• MODEL 9200 VIS-U-SCAN by Del Mar Avionics
• MODEL MR-30 HOLTER RECORDER by Oxford Medilog, Inc.
• BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER by Braemar Corp.
• AMBULATORY MONITOR AM-1 by Burdick Corp.
• VITALOGRAPH 2110 SOFTWARE INTERFACE by Vitalograph, Ltd.

• Peerbridge COR MDx (Cor MDx)

  Class II

  FDA 510(k) K253529 Active Cleared 4 Sep 2026

• Peerbridge Cor System CORXT

  Class II

  FDA 510(k) K171936 Active Cleared 27 Sep 2017 GUDID on market

• Peerbridge Cor System COREVENT

  Class II

  FDA 510(k) K171936 Active Cleared 27 Sep 2017 GUDID on market