BRAEMAR FUSION WIRELESS – AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM


Device Classification Name

detector and alarm, arrhythmia

510(k) Number K081444
Device Name BRAEMAR FUSION WIRELESS – AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
Applicant
BRAEMAR, INC.
1285 corporate center dr.
suite 150
eagan, 
MN 
55121

Applicant Contact darren dershem
Correspondent
BRAEMAR, INC.
1285 corporate center dr.
suite 150
eagan, 
MN 
55121

Correspodent Contact darren dershem
Regulation Number 870.1025
Classification Product Code
DSI  
Subsequent Product Code
DRG  
Date Received 05/22/2008
Decision Date 07/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No