The following data is part of a premarket notification filed by Decubiti Concepts, Inc. with the FDA for Alternating Pressure Air Flotation Mattress.
| Device ID | K972153 |
| 510k Number | K972153 |
| Device Name: | ALTERNATING PRESSURE AIR FLOTATION MATTRESS |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | DECUBITI CONCEPTS, INC. PO BOX 1026 MT. PLEASANT,, SC 29465 -1026 |
| Contact | JEAN ROZINT |
| Correspondent | JEAN ROZINT DECUBITI CONCEPTS, INC. PO BOX 1026 MT. PLEASANT,, SC 29465 -1026 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1997-07-31 |