The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Quadrature Ctl Array Coil.
| Device ID | K984159 |
| 510k Number | K984159 |
| Device Name: | MEDRAD QUADRATURE CTL ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Jim Ferguson Jr |
| Correspondent | Jim Ferguson Jr MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-19 |
| Decision Date | 1999-01-12 |
| Summary: | summary |