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Cardionet, LLC: FDA-registered device maker in Linwood, PA, United States, 2 510(k) clearances

Name: Cardionet, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cardionet, LLC is registered with the FDA (registration 3016812424) in Linwood, PA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 4, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016812424
Address: 600 West Ridge Road, Linwood, PA, United States, 19061
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Complaint file establishment, Contract manufacturer
First device listed: November 12, 2003
Registered through: 2026
Brand names listed: 2-CH Patch, 40494E, Limb Clamp Electrode, 989803157481, DigiTrak XT Patient Cable, short, 989803157491, DigiTrak XT Patient Cable, Medium, 989803157501, DigiTrak XT Patient Cable, Long, BTP-1000A-Hybrid Patch, BTP-1000L-2-Lead Wire Adapter, BTP-1000M (Monitor) and more

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Recorder, Magnetic Tape, Medical	DSH	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 4, 2018	K171410	ePatch	DSH	Substantially Equivalent	Braemar Manufacturing, LLC	accessdata.fda.gov
July 22, 2016	K153473	Braemar Telemetry Patch System	DSI	Substantially Equivalent	Braemar Manufacturing, LLC	accessdata.fda.gov

Compare with other makers

Updated January 4, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.