BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM

Detector And Alarm, Arrhythmia

BRAEMAR, INC.

The following data is part of a premarket notification filed by Braemar, Inc. with the FDA for Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring System.

Pre-market Notification Details

Device IDK081444
510k NumberK081444
Device Name:BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
ClassificationDetector And Alarm, Arrhythmia
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 CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-22
Decision Date2008-07-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B146FUSTLC0 K081444 000
B146FUSLS0 K081444 000
B146FUSFCM0 K081444 000
B146FUSB0 K081444 000

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