The following data is part of a premarket notification filed by Tecnomed, Inc. with the FDA for Tec 6340 90/15 Radiographic/fluoroscopic Table.
| Device ID | K892226 |
| 510k Number | K892226 |
| Device Name: | TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE |
| Classification | Table, Radiographic, Tilting |
| Applicant | TECNOMED, INC. 235 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Contact | Jean Griswold |
| Correspondent | Jean Griswold TECNOMED, INC. 235 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-04 |
| Decision Date | 1989-04-26 |