The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Cla-1400 System.
| Device ID | K914851 |
| 510k Number | K914851 |
| Device Name: | CLA-1400 SYSTEM |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Contact | Peter Scott |
| Correspondent | Peter Scott GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-28 |
| Decision Date | 1991-11-13 |