The following data is part of a premarket notification filed by Stuart Medical, Inc. with the FDA for Meditech Euroscanner M250.
| Device ID | K850027 |
| 510k Number | K850027 |
| Device Name: | MEDITECH EUROSCANNER M250 |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | STUART MEDICAL, INC. 9190 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Stuart L Gallant |
| Correspondent | Stuart L Gallant STUART MEDICAL, INC. 9190 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-04 |
| Decision Date | 1985-04-04 |