The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad 1.5t, 1.0t & 0.5t Shoulder Coil, Models M64shc, M42shc, M21shc.
Device ID | K982916 |
510k Number | K982916 |
Device Name: | MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC |
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 | 1998-08-19 |
Decision Date | 1998-10-29 |
Summary: | summary |