The following data is part of a premarket notification filed by Pegasus Airwave, Inc. with the FDA for Pegasus Airwave Syst/spec Mattress Decubitus Ulcer.
| Device ID | K874877 |
| 510k Number | K874877 |
| Device Name: | PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | PEGASUS AIRWAVE, INC. PORTSMOUTH ENTERPRISE CENTRE QUARTREMAINE ROAD, PORTSMOUTH Hants Po35qt, England, GB |
| Contact | Welch |
| Correspondent | Welch PEGASUS AIRWAVE, INC. PORTSMOUTH ENTERPRISE CENTRE QUARTREMAINE ROAD, PORTSMOUTH Hants Po35qt, England, GB |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-13 |
| Decision Date | 1988-02-22 |