The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Image Full Power Examination/minor Surgery Table.
| Device ID | K942486 |
| 510k Number | K942486 |
| Device Name: | IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE |
| Classification | Table, Operating-room, Ac-powered |
| Applicant | MDT CORP., INC. 1777 EAST HENRIETTA RD. Rochester, NY 14623 |
| Contact | Mark N Smith, P.e. |
| Correspondent | Mark N Smith, P.e. MDT CORP., INC. 1777 EAST HENRIETTA RD. Rochester, NY 14623 |
| Product Code | FQO |
| Subsequent Product Code | FWW |
| Subsequent Product Code | GDL |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-25 |
| Decision Date | 1994-08-10 |