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
|
|
Correspondent Contact |
ALEX GONOROVSKY |
Regulation Number | 870.1025
|
Classification Product Code |
|
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
|
|
|