Device Classification Name |
detector and alarm, arrhythmia
|
510(k) Number |
K110499 |
Device Name |
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR |
Applicant |
CARD GUARD SCIENTIFIC SURVIVAL LTD. |
555 ZANG ST |
SUITE 100 |
lakewood,
CO
80228
|
|
Applicant Contact |
clay anselmo |
Correspondent |
CARD GUARD SCIENTIFIC SURVIVAL LTD. |
555 ZANG ST |
SUITE 100 |
lakewood,
CO
80228
|
|
Correspondent Contact |
clay anselmo |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/22/2011 |
Decision Date | 04/06/2011 |
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
|
|
|