The following data is part of a premarket notification filed by Magnetic Research, Inc. with the FDA for Qquadrature Lumbar Contour Coil.
Device ID | K922006 |
510k Number | K922006 |
Device Name: | QQUADRATURE LUMBAR CONTOUR COIL |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | MAGNETIC RESEARCH, INC. 695 EAST 1700 NORTH Mapleton, UT 84664 |
Contact | Sanford Larsen |
Correspondent | Sanford Larsen 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 | 1992-04-30 |
Decision Date | 1992-07-29 |