Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K071995 |
Device Name |
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR |
Applicant |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. P.O. BOX 527 |
REHOVOT,
IL
76101
|
|
Applicant Contact |
ALEX GONOROVSKY |
Correspondent |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
2 PEKERIS ST. P.O. BOX 527 |
REHOVOT,
IL
76101
|
|
Correspondent Contact |
ALEX GONOROVSKY |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/20/2007 |
Decision Date | 12/18/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|