The following data is part of a premarket notification filed by Mr Instruments, Inc with the FDA for Duoflex Coil Suite.
| Device ID | K173290 |
| 510k Number | K173290 |
| Device Name: | DuoFLEX Coil Suite |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MR Instruments, Inc 5610 Rowland Road, Suite 145 Minnetonka, MN 55343 |
| Contact | Leon Ricord |
| 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 | 2017-10-16 |
| Decision Date | 2017-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857371006380 | K173290 | 000 |
| 00857371006236 | K173290 | 000 |
| 00857371006229 | K173290 | 000 |
| 00857371006212 | K173290 | 000 |
| 00857371006205 | K173290 | 000 |
| 00857371006175 | K173290 | 000 |
| 00857371006168 | K173290 | 000 |
| 00857371006151 | K173290 | 000 |
| 00857371006144 | K173290 | 000 |
| 00857371006243 | K173290 | 000 |
| 00857371006274 | K173290 | 000 |
| 00857371006373 | K173290 | 000 |
| 00857371006366 | K173290 | 000 |
| 00857371006359 | K173290 | 000 |
| 00857371006342 | K173290 | 000 |
| 00857371006311 | K173290 | 000 |
| 00857371006304 | K173290 | 000 |
| 00857371006298 | K173290 | 000 |
| 00857371006281 | K173290 | 000 |
| 00857371006137 | K173290 | 000 |