The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Clinidyne Rotational Therapy Mattress System.
| Device ID | K962788 |
| 510k Number | K962788 |
| Device Name: | CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM |
| Classification | Bed, Patient Rotation, 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 | IKZ |
| Subsequent Product Code | FNM |
| Subsequent Product Code | IOQ |
| CFR Regulation Number | 890.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-17 |
| Decision Date | 1997-04-30 |
| Summary: | summary |