The following data is part of a premarket notification filed by Mr Instruments, Inc. with the FDA for Duoflex Coil Suite (1.5t).
| Device ID | K130706 |
| 510k Number | K130706 |
| Device Name: | DUOFLEX COIL SUITE (1.5T) |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MR INSTRUMENTS, INC. 5610 ROWLAND RD. SUITE 145 Minneapolis, MN 54343 |
| Contact | Robert Beck |
| 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 | 2013-03-15 |
| Decision Date | 2013-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857371006014 | K130706 | 000 |