510(k) K172770

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

K172770 is an FDA 510(k) premarket notification submitted by Airos Medical, Inc. for the device "AIROS 6 Sequential Compression Device". The FDA issued a decision of Substantially Equivalent on June 22, 2018. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Airos Medical, Inc. has at least 6 other 510(k) clearances on record.

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