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 |