The following data is part of a premarket notification filed by Gsi Development Co. with the FDA for Fluidized Air Bed.
| Device ID | K893708 |
| 510k Number | K893708 |
| Device Name: | FLUIDIZED AIR BED |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | GSI DEVELOPMENT CO. 2 COMMERCE DR. Carmel, NY 10512 |
| Contact | Oliver Bodine |
| Correspondent | Oliver Bodine GSI DEVELOPMENT CO. 2 COMMERCE DR. Carmel, NY 10512 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-18 |
| Decision Date | 1989-06-22 |