Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K101639 |
Device Name |
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR |
Applicant |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
555 ZANG STREET |
SUITE 100 |
LAKEWOOD,
CO
80228
|
|
Applicant Contact |
CLAY ANSELMO |
Correspondent |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
555 ZANG STREET |
SUITE 100 |
LAKEWOOD,
CO
80228
|
|
Correspondent Contact |
CLAY ANSELMO |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/10/2010 |
Decision Date | 06/25/2010 |
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
|
|
|