Device Classification Name |
electrocardiograph
|
510(k) Number |
K032145 |
Device Name |
AUDICOR UPGRADE SYSTEM |
Applicant |
INOVISE MEDICAL, INC. |
1025 INDUSTRIAL PKWY. |
SUITE C |
newberg,
OR
97132
|
|
Applicant Contact |
steve hesler |
Correspondent |
INOVISE MEDICAL, INC. |
1025 INDUSTRIAL PKWY. |
SUITE C |
newberg,
OR
97132
|
|
Correspondent Contact |
steve hesler |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 07/14/2003 |
Decision Date | 10/31/2003 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|