MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER

Electrocardiograph, Ambulatory (without Analysis)

BRAEMAR, INC.

The following data is part of a premarket notification filed by Braemar, Inc. with the FDA for Modification To: Braemar Er900 Series Enhanced Algorithm Ecg Event Recorder.

Pre-market Notification Details

Device IDK071011
510k NumberK071011
Device Name:MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
ClassificationElectrocardiograph, Ambulatory (without Analysis)
Applicant BRAEMAR, INC. 1285 CORPORATE CENTER DR. SUITE 150 Eagan,  MN  55121
ContactDarren Dershem
CorrespondentDarren Dershem
BRAEMAR, INC. 1285 CORPORATE CENTER DR. SUITE 150 Eagan,  MN  55121
Product CodeMWJ  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-10
Decision Date2007-04-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B146PERP0 K071011 000
B146PERB0 K071011 000
B146ER9RAF0 K071011 000
B146ER9R0 K071011 000
B146ER9BAF0 K071011 000
B146ER9B0 K071011 000

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