The following data is part of a premarket notification filed by Tecnomed, Inc. with the FDA for Automatic Film Processorio M. R80.
| Device ID | K781068 |
| 510k Number | K781068 |
| Device Name: | AUTOMATIC FILM PROCESSORIO M. R80 |
| Classification | Barrier, Control Panel, X-ray, Movable |
| Applicant | TECNOMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IWX |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-26 |
| Decision Date | 1978-07-17 |