Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011265784

FEI Number

3011265784

Entity Name

Rhythmedix

City/State/Country

Mount Laurel, NJ, US

Establishment Address

Horizon Corporate Center, 5000 Atrium Way, Suite 1, Mount Laurel, NJ 08054, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Rhythmedix (Owner Number: 10047405)

Owner / Operator Contact Address

Horizon Corporate Center, 5000 Atrium Way, Suite 1, Mount Laurel, NJ 08054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141813

PMA Number

N/A

All Registered Proprietary Names

RhythmStar System RhythmStar BodyGuardian ONE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QYX	Outpatient Cardiac Telemetry	Cardiovascular	Class 2	870.1025	2024-10-08
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2014-08-25

Official Correspondent

Stan Biletsky

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rhythmedix

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K820986	Dart Medical Equipment	EKG MONITORS, VARIOUS MODELS	1982-04-29
K910450	Medtech Industries, Inc.	CARD GUARD-3000 ECG TELEPHONE ADAPTER	1991-05-07
K761318	Cambridge Instruments, Inc.	3038 OPTION B-COMPUT. TRANS. TERMINAL	1977-01-06
K972649	Reynolds Medical , Ltd.	CARDIOCALL CARDIAC EVENT RECORDER	1997-12-04
K033410	Remote Diagnostic Technologies , Ltd.	TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002	2004-03-05

Similar Registrations

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3011937459	VivaQuant, Inc	Arden Hills, MN, US
3007770164	MEDICALGORITHMICS S.A.	WARSAW Mazowieckie, PL
3009883402	Boston Scientific Cardiac Diagnostic Technologies, Inc.	ROCHESTER, MN, US
3022298579	Boston Scientific Cardiac Diagnostic Technologies, Inc.	Arden Hills, MN, US
3029904429	SMARTCARDIA SA	Lausanne Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011265784. Last updated year: 2026. Please use registration number 3011265784 when referencing this establishment in official correspondence.