CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR


Device Classification Name

detector and alarm, arrhythmia

510(k) Number K081257
Device Name CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 pekeris st., science park
rehovot, 

IL

76100

Applicant Contact alex gonorovsky
Correspondent
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 pekeris st., science park
rehovot, 

IL

76100

Correspodent Contact alex gonorovsky
Regulation Number 870.1025
Classification Product Code
DSI  
Date Received 05/02/2008
Decision Date 05/29/2008
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