510(k) K172770

AIROS 6 Sequential Compression Device by Airos Medical, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2018
Date Received
September 14, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type