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FDA 510(k)

BRAEMAR CARDIOKEY HOLTER RECORDER

K-Number: K130294 · 2013-10-16

ApplicantBraemar Manufacturing, LLC
Decision Date2013-10-16
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BRAEMAR CARDIOKEY HOLTER RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Braemar Manufacturing, LLC. It received FDA 510(k) clearance on 2013-10-16 under 510(k) number K130294. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAEMAR CARDIOKEY HOLTER RECORDER?

BRAEMAR CARDIOKEY HOLTER RECORDER is a medical device that received FDA 510(k) clearance on 2013-10-16. The listed applicant is Braemar Manufacturing, LLC. The 510(k) number is K130294.

When did BRAEMAR CARDIOKEY HOLTER RECORDER receive FDA 510(k) clearance?

BRAEMAR CARDIOKEY HOLTER RECORDER received FDA 510(k) clearance on 2013-10-16, under 510(k) number K130294.

Who is the listed applicant for BRAEMAR CARDIOKEY HOLTER RECORDER?

The FDA 510(k) record lists Braemar Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRAEMAR CARDIOKEY HOLTER RECORDER?

The FDA product code for BRAEMAR CARDIOKEY HOLTER RECORDER is MWJ.

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Other records listing Braemar Manufacturing, LLC as applicant

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Related Devices (Code: MWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)Shenzhen Xinyan Medical Technology Co.,ltd.K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.K253562medilogFDSchiller AGK253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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