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FDA 510(k)

BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER

K-Number: K072008 · 2007-10-03

ApplicantBraemar, Inc.
Decision Date2007-10-03
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Braemar, Inc.. It received FDA 510(k) clearance on 2007-10-03 under 510(k) number K072008. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER?

BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER is a medical device that received FDA 510(k) clearance on 2007-10-03. The listed applicant is Braemar, Inc.. The 510(k) number is K072008.

When did BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER receive FDA 510(k) clearance?

BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER received FDA 510(k) clearance on 2007-10-03, under 510(k) number K072008.

Who is the listed applicant for BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER?

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

What is the FDA product code for BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER?

The FDA product code for BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER is DRG.

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Other records listing Braemar, Inc. 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.

K081444BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEMK071733DL900 SERIES HOLTER RECORDERK071011MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDERK042469BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER

Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, 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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