CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR


Device Classification Name

detector and alarm, arrhythmia

510(k) Number K110499
Device Name CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
Applicant
CARD GUARD SCIENTIFIC SURVIVAL LTD.
555 zang st
suite 100
lakewood, 
CO 
80228

Applicant Contact clay anselmo
Correspondent
CARD GUARD SCIENTIFIC SURVIVAL LTD.
555 zang st
suite 100
lakewood, 
CO 
80228

Correspodent Contact clay anselmo
Regulation Number 870.1025
Classification Product Code
DSI  
Subsequent Product Code
DXH  
Date Received 02/22/2011
Decision Date 04/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls