510(k) K072185

AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000 by Airistar Technologies, LLC — Product Code FRF

K072185 is an FDA 510(k) premarket notification submitted by Airistar Technologies, LLC for the device "AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000". The FDA issued a decision of Substantially Equivalent on March 27, 2008. The device falls under product code FRF (Cleaner, Air, Medical Recirculating), a Class II device regulated under 21 CFR 880.5045.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2008
Date Received
August 6, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Cleaner, Air, Medical Recirculating
Device Class
Class II
Regulation Number
880.5045
Review Panel
HO
Submission Type