The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Key Med Transendoscopic Vascular Detector Tvd-1.
| Device ID | K851149 |
| 510k Number | K851149 |
| Device Name: | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 |
| Classification | Monitor, Ultrasonic, Nonfetal |
| 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 | JAF |
| CFR Regulation Number | 892.1540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-21 |
| Decision Date | 1985-11-26 |