The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak X-omat M43a, M43, & Clinic 1 Processors.
| Device ID | K934350 |
| 510k Number | K934350 |
| Device Name: | KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS |
| Classification | Processor, Radiographic-film, Automatic |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Douglas Hall |
| Correspondent | Douglas Hall EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | IXW |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-07 |
| Decision Date | 1994-03-21 |