Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K183349 |
Device Name |
AeroDVx System |
Applicant |
Sun Scientific Inc |
145 Palisade Street |
Dobbs Ferry,
NY
10522
|
|
Applicant Contact |
Allan Alward |
Correspondent |
Sun Scientific Inc |
145 Palisade Street |
Dobbs Ferry,
NY
10522
|
|
Correspondent Contact |
Allan Alward |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 12/03/2018 |
Decision Date | 07/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|