The following data is part of a premarket notification filed by Magnetic Research, Inc. with the FDA for Quadrature Shoulder Contour Coil.
| Device ID | K920227 |
| 510k Number | K920227 |
| Device Name: | QUADRATURE SHOULDER CONTOUR COIL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MAGNETIC RESEARCH, INC. 695 EAST 1700 NORTH Mapleton, UT 84664 |
| Contact | Wendell A Gibby |
| Correspondent | Wendell A Gibby MAGNETIC RESEARCH, INC. 695 EAST 1700 NORTH Mapleton, UT 84664 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-17 |
| Decision Date | 1992-08-24 |