510(k) K780906
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