The following data is part of a premarket notification filed by Gsi Development Co. with the FDA for Microair 3500.
| Device ID | K914674 |
| 510k Number | K914674 |
| Device Name: | MICROAIR 3500 |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | GSI DEVELOPMENT CO. 2 COMMERCE DR. Carmel, NY 10512 |
| Contact | Oliver H Bodine |
| Correspondent | Oliver H 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 | 1991-10-18 |
| Decision Date | 1991-11-22 |