The following data is part of a premarket notification filed by Midwest R.f. Llc. with the FDA for Model 1300ge-64: Pediatric Positioner.
| Device ID | K030317 |
| 510k Number | K030317 |
| Device Name: | MODEL 1300GE-64: PEDIATRIC POSITIONER |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MIDWEST R.F. LLC. 535 NORTON DR. Hartland, WI 53029 |
| Contact | Helmut Keidl |
| Correspondent | Helmut Keidl MIDWEST R.F. LLC. 535 NORTON DR. Hartland, WI 53029 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-30 |
| Decision Date | 2003-03-25 |
| Summary: | summary |