The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Qwik-fix Mri Disposable Kit.
| Device ID | K943189 |
| 510k Number | K943189 |
| Device Name: | MEDRAD QWIK-FIX MRI DISPOSABLE KIT |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDRAD, INC. P.O. BOX 780, MEDRAD DR. OFF RTE 910 Indianola, PA 15051 |
| Contact | Jan Burtick |
| Correspondent | Jan Burtick MEDRAD, INC. P.O. BOX 780, MEDRAD DR. OFF RTE 910 Indianola, PA 15051 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-05 |
| Decision Date | 1995-08-09 |