The following data is part of a premarket notification filed by Pegasus Airwave, Inc. with the FDA for Pegasus Biwave Plus System.
| Device ID | K944310 |
| 510k Number | K944310 |
| Device Name: | PEGASUS BIWAVE PLUS SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | PEGASUS AIRWAVE, INC. 640 SOUTH MILITAY TRAIL Deerfield Beach, FL 33442 |
| Contact | Thomas R Harrision |
| Correspondent | Thomas R Harrision PEGASUS AIRWAVE, INC. 640 SOUTH MILITAY TRAIL Deerfield Beach, FL 33442 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-02 |
| Decision Date | 1995-03-17 |