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MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER — Braemar, Inc. (510(k) K071011)

MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER — Braemar, Inc. (510(k) K071011) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER; Applicant: Braemar, Inc.; Clearance track: 51

Device nameMODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
ApplicantBraemar, Inc.
Clearance track510(k)
Submission numberK071011
DecisionSubstantially Equivalent
Decision date2007-04-27
Date received2007-04-10
Product codeMWJ
Device class2
Medical specialtyCardiovascular
Applicant locationMN, US
SourceopenFDA device

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