Device Classification Name |
electrocardiograph, ambulatory, with analysis algorithm
|
510(k) Number |
K120462 |
Device Name |
AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) |
Applicant |
INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVE. |
SUITE D |
beaverton,
OR
97008
|
|
Applicant Contact |
earl anderson |
Correspondent |
INOVISE MEDICAL, INC. |
8770 SW NIMBUS AVE. |
SUITE D |
beaverton,
OR
97008
|
|
Correspondent Contact |
earl anderson |
Regulation Number | 870.2800
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/15/2012 |
Decision Date | 09/20/2012 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|