Device Classification Name |
electrode, electrocardiograph
|
510(k) Number |
K080602 |
Device Name |
AUDICOR SENSOR, MODELS: 2.0, 3.0 |
Applicant |
INOVISE MEDICAL, INC. |
10565 SW NIMBUS AVE. |
SUITE 100 |
PORTLAND,
OR
97223
|
|
Applicant Contact |
KENDRA RATHKEY |
Correspondent |
INOVISE MEDICAL, INC. |
10565 SW NIMBUS AVE. |
SUITE 100 |
PORTLAND,
OR
97223
|
|
Correspondent Contact |
KENDRA RATHKEY |
Regulation Number | 870.2360
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/03/2008 |
Decision Date | 09/25/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|