The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Anterior Neck Coil, 1.5t & 1.0t Model Numbers M64anc And M42anc.
Device ID | K982932 |
510k Number | K982932 |
Device Name: | MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
Contact | Jim Ferguson |
Correspondent | Jim Ferguson MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-20 |
Decision Date | 1998-11-02 |
Summary: | summary |