Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K200564 |
Device Name |
Aria System |
Applicant |
Inova Labs |
7581 Convoy Court |
San Diego,
CA
92111
|
|
Applicant Contact |
Reuben Lawson |
Correspondent |
Accelerated Device Approval Services |
6800 S.W. 40th Street, Ste. 403 |
Ludlum,
FL
33155
|
|
Correspondent Contact |
Rafael Aguila |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 03/04/2020 |
Decision Date | 04/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|