The following data is part of a premarket notification filed by Scientex Corp. with the FDA for 105mm Roll Film Fluorogr. Camera, #105.
| Device ID | K810072 |
| 510k Number | K810072 |
| Device Name: | 105MM ROLL FILM FLUOROGR. CAMERA, #105 |
| Classification | Camera, X-ray, Fluorographic, Cine Or Spot |
| Applicant | SCIENTEX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IZJ |
| CFR Regulation Number | 892.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-13 |
| Decision Date | 1981-02-12 |