510(k) K811684

AMERICAN AIRCARE SYSTEM by American Hamilton — Product Code FNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1981
Date Received
June 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Air Flotation, Alternating Pressure
Device Class
Class II
Regulation Number
880.5550
Review Panel
HO
Submission Type