The following data is part of a premarket notification filed by Mr Instruments, Inc. with the FDA for Mc 1504g-16r, 1.5t, 16-channel, Mc 3004g-16r, 3.0t, 16-channel Head Coil.
| Device ID | K110591 |
| 510k Number | K110591 |
| Device Name: | MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MR INSTRUMENTS, INC. 5610 ROWLAND ROAD SUITE 145 Minnetonka, MN 55343 |
| Contact | Joshua J Holwell |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-03-02 |
| Decision Date | 2011-03-29 |
| Summary: | summary |