The following data is part of a premarket notification filed by Omnimedical Services, Inc. with the FDA for Omnimedical 400l.
| Device ID | K771990 |
| 510k Number | K771990 |
| Device Name: | OMNIMEDICAL 400L |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | OMNIMEDICAL SERVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-19 |
| Decision Date | 1977-11-30 |