The following data is part of a premarket notification filed by Magnetic Research, Inc. with the FDA for Quadrature Cervical Contour Coil.
Device ID | K923881 |
510k Number | K923881 |
Device Name: | QUADRATURE CERVICAL 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 | 1992-08-04 |
Decision Date | 1992-11-05 |