Device Classification Name |
electrocardiograph
|
510(k) Number |
K070136 |
Device Name |
AUDICOR 200 SYSTEM, MODELS 200D AND 200S |
Applicant |
INOVISE MEDICAL, INC. |
10565 SW NIMBUS AVE. |
SUITE 100 |
portland,
OR
97223
|
|
Applicant Contact |
steve hesler |
Correspondent |
INOVISE MEDICAL, INC. |
10565 SW NIMBUS AVE. |
SUITE 100 |
portland,
OR
97223
|
|
Correspondent Contact |
steve hesler |
Regulation Number | 870.2340
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/16/2007 |
Decision Date | 04/13/2007 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|