The following data is part of a premarket notification filed by Magnetic Research, Inc. with the FDA for Quadrature Small Extremity Coil.
| Device ID | K935015 |
| 510k Number | K935015 |
| Device Name: | QUADRATURE SMALL EXTREMITY COIL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MAGNETIC RESEARCH, INC. 42 NORTH UNIVERSITY AVE. SUITE 204 Provo, UT 84601 |
| Contact | Wendell A Gibby |
| Correspondent | Wendell A Gibby MAGNETIC RESEARCH, INC. 42 NORTH UNIVERSITY AVE. SUITE 204 Provo, UT 84601 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-19 |
| Decision Date | 1994-05-10 |