510(k) K223835

MA-40, MA-112 by Medify Air, LLC — Product Code FRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2023
Date Received
December 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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