The following data is part of a premarket notification filed by Medifloat, Inc. with the FDA for Medair Excel 2000.
| Device ID | K942920 |
| 510k Number | K942920 |
| Device Name: | MEDAIR EXCEL 2000 |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | MEDIFLOAT, INC. 123 ORCHARD STREET, SUITE 1A ORMOND BEACH, FL 32174 |
| Contact | D. RAY STINSON |
| Correspondent | D. RAY STINSON MEDIFLOAT, INC. 123 ORCHARD STREET, SUITE 1A ORMOND BEACH, FL 32174 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-21 |
| Decision Date | 1994-09-19 |