Rhythmstar System

510(k) Number

K141813 ↗

FDA product code

DXH

Device class

Class II

Regulation

21 CFR Part 870.2920

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 DXH (Transmitters And Receivers, Electrocardiograph, Telephone).

• HEALTHEPOD by Card Guard Scientific Survival, Ltd.
• EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM by Reynolds Medical, Ltd.
• TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM by Telescan Medical Systems
• CARDIOMAGIC SOFTWARE by Instromedix, Inc.
• HEARTRAK AF by UNIVERSAL MEDICAL, INC.
• CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306 by Card Guard Scientific Survival, Ltd.
• T-1000 ECG TRANSMITTER by Brentwood Instruments, Inc.
• SIRECUST 456 by ANALOGIC CORPORATION
• MODEL 4242 TELE SYST ARRHYTHMIA MONITOR by MEDTRONIC VASCULAR, INC.
• HEART 1001 by Aerotel, Ltd.

• RhythmStar System SL

  Class II

  FDA 510(k) K250793 Active Cleared 21 Apr 2026 GUDID on market

• RhythmStar RS-10002V

  Class II

  FDA 510(k) K141813 Active Cleared 5 Aug 2014 GUDID on market

• RhythmStar RS-10003

  Class II

  FDA 510(k) ×2 Active Cleared 5 Aug 2014 GUDID on market

• RhythmStar System (SL)

  Class II

  FDA 510(k) K250793 Active Cleared 21 Apr 2026

See all devices from RhythMedix, LLC →