The following data is part of a premarket notification filed by Mr Instruments, Inc. with the FDA for Mc 3003g-32r Head Coil.
| Device ID | K072931 |
| 510k Number | K072931 |
| Device Name: | MC 3003G-32R HEAD COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MR INSTRUMENTS, INC. 5610 ROWLAND ROAD SUITE 145 Minnetonka, MN 55343 |
| Contact | Mark Watson |
| 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 | 2007-10-16 |
| Decision Date | 2007-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857371006007 | K072931 | 000 |