Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K172770 |
Device Name |
AIROS 6 Sequential Compression Device |
Applicant |
AIROS Medical, Inc. |
2501 Monroe Blvd, Suite 1200 |
Audubon,
PA
19403
|
|
Applicant Contact |
Darren Behuniak |
Correspondent |
AIROS Medical, Inc. |
2501 Monroe Blvd, Suite 1200 |
Audubon,
PA
19403
|
|
Correspondent Contact |
Darren Behuniak |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 09/14/2017 |
Decision Date | 06/22/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|