The following data is part of a premarket notification filed by International Medical Designs, Inc. with the FDA for Model Mpft-01, Genesis.
| Device ID | K934574 |
| 510k Number | K934574 |
| Device Name: | MODEL MPFT-01, GENESIS |
| Classification | Table, Radiographic, Tilting |
| Applicant | INTERNATIONAL MEDICAL DESIGNS, INC. 303 ELNORA AVE. Deltona, FL 32738 |
| Contact | George Grabowski |
| Correspondent | George Grabowski INTERNATIONAL MEDICAL DESIGNS, INC. 303 ELNORA AVE. Deltona, FL 32738 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-16 |
| Decision Date | 1994-03-04 |