510(k) K780906

AIR-FLO ALTERNATING PRESSURE PAD SYSTEM by Gaymar Industries, Inc. — Product Code FNM

K780906 is an FDA 510(k) premarket notification submitted by Gaymar Industries, Inc. for the device "AIR-FLO ALTERNATING PRESSURE PAD SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 10, 1978. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Gaymar Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 10, 1978
Date Received
Jun 2, 1978
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