The following data is part of a premarket notification filed by Magnetic Research, Inc. with the FDA for Phased Array/bilateral Quadrature Contour Coil.
Device ID | K932091 |
510k Number | K932091 |
Device Name: | PHASED ARRAY/BILATERAL QUADRATURE CONTOUR 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 | 1993-04-30 |
Decision Date | 1993-12-14 |