Device Classification Name |
oximeter
|
510(k) Number |
K160582 |
Device Name |
WiCap |
Applicant |
Athena GTX |
5900 NW 86th Street, Suite 300 |
Johnston,
IA
50131
|
|
Applicant Contact |
Sean Mahoney |
Correspondent |
Athena GTX |
5900 NW 86th Street, Suite 300 |
Johnston,
IA
50131
|
|
Correspondent Contact |
Sean Mahoney |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/01/2016 |
Decision Date | 09/02/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|