The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for The Keymed Vari-height Patient Couch.
| Device ID | K853421 |
| 510k Number | K853421 |
| Device Name: | THE KEYMED VARI-HEIGHT PATIENT COUCH |
| Classification | Stretcher, Wheeled |
| Applicant | KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England, GB |
| Contact | Roger Gray |
| Correspondent | Roger Gray KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England, GB |
| Product Code | FPO |
| CFR Regulation Number | 880.6910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-14 |
| Decision Date | 1985-09-19 |