510(k) K872228

PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM by American Pharmaseal Div. Ahsc — Product Code FNM

K872228 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM". The FDA issued a decision of Substantially Equivalent on September 4, 1987. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1987
Date Received
June 9, 1987
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