BRAEMAR ER800 SERIES ENHANCED ALGORITHM 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 Braemar Er800 Series Enhanced Algorithm Event Recorder.

Pre-market Notification Details

Device IDK042469
510k NumberK042469
Device Name:BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
ClassificationElectrocardiograph, Ambulatory (without Analysis)
Applicant BRAEMAR, INC. 11481 RUPP DR. Burnsville,  MN  55337
ContactDarren Dershem
CorrespondentDarren Dershem
BRAEMAR, INC. 11481 RUPP DR. Burnsville,  MN  55337
Product CodeMWJ  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-13
Decision Date2004-10-06

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