The following data is part of a premarket notification filed by International Medical Designs, Inc. with the FDA for Model Fp-100.
| Device ID | K942019 |
| 510k Number | K942019 |
| Device Name: | MODEL FP-100 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | INTERNATIONAL MEDICAL DESIGNS, INC. 303 ELNORA AVE. Deltona, FL 32738 |
| Contact | George Gabrowski |
| Correspondent | George Gabrowski INTERNATIONAL MEDICAL DESIGNS, INC. 303 ELNORA AVE. Deltona, FL 32738 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-26 |
| Decision Date | 1995-02-01 |