The following data is part of a premarket notification filed by Surgi-med, Inc. with the FDA for Model 5000 Air-fluidized Support System.
| Device ID | K881705 |
| 510k Number | K881705 |
| Device Name: | MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM |
| Classification | Bed, Air Fluidized |
| Applicant | SURGI-MED, INC. 815 TERMINAL RD. Lansing, MI 48906 |
| Contact | Donald Propp |
| Correspondent | Donald Propp SURGI-MED, INC. 815 TERMINAL RD. Lansing, MI 48906 |
| Product Code | INX |
| CFR Regulation Number | 890.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-19 |
| Decision Date | 1988-07-13 |