Device Classification Name |
Electrocardiograph, Ambulatory (Without Analysis)
|
510(k) Number |
K001349 |
Device Name |
CARDIOVISE ECG INTERPRETATIVE SOFTWARE |
Applicant |
INOVISE MEDICAL, INC. |
1025 INDUSTRIAL PKWY. |
SUITE C |
NEWBERG,
OR
97132
|
|
Applicant Contact |
DEBRA A OLSON |
Correspondent |
INOVISE MEDICAL, INC. |
1025 INDUSTRIAL PKWY. |
SUITE C |
NEWBERG,
OR
97132
|
|
Correspondent Contact |
DEBRA A OLSON |
Regulation Number | 870.2800
|
Classification Product Code |
|
Date Received | 04/28/2000 |
Decision Date | 07/27/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|