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FDA 510(k)

ER800 SERIES ECG EVENT RECORDER

K-Number: K030856 · 2003-03-28

ApplicantBraemar Corp.
Decision Date2003-03-28
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ER800 SERIES ECG EVENT RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Braemar Corp.. It received FDA 510(k) clearance on 2003-03-28 under 510(k) number K030856. 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 ER800 SERIES ECG EVENT RECORDER?

ER800 SERIES ECG EVENT RECORDER is a medical device that received FDA 510(k) clearance on 2003-03-28. The listed applicant is Braemar Corp.. The 510(k) number is K030856.

When did ER800 SERIES ECG EVENT RECORDER receive FDA 510(k) clearance?

ER800 SERIES ECG EVENT RECORDER received FDA 510(k) clearance on 2003-03-28, under 510(k) number K030856.

Who is the listed applicant for ER800 SERIES ECG EVENT RECORDER?

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

What is the FDA product code for ER800 SERIES ECG EVENT RECORDER?

The FDA product code for ER800 SERIES ECG EVENT RECORDER is MWJ.

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Other records listing Braemar Corp. as applicant

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.

K993617DIGITRAKPLUS HOLTER RECORDERK993618DXP1000 HOLTER RECORDERK981394BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720K945130BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER

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

View on FDA Database →

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

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