Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K101703 |
Device Name |
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 |
Applicant |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
555 ZANG STREET |
SUITE 100 |
LAKEWOOD,
CO
80228
|
|
Applicant Contact |
CLAY ANESELMO |
Correspondent |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
555 ZANG STREET |
SUITE 100 |
LAKEWOOD,
CO
80228
|
|
Correspondent Contact |
CLAY ANESELMO |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/17/2010 |
Decision Date | 07/13/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|