The following data is part of a premarket notification filed by Mr Instruments Inc. with the FDA for Tem 3000 Head Coil.
| Device ID | K052200 |
| 510k Number | K052200 |
| Device Name: | TEM 3000 HEAD COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MR INSTRUMENTS INC. 4802 PARK GLEN ROAD Minneapolis, MN 55416 |
| 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 | 2005-08-12 |
| Decision Date | 2005-08-19 |
| Summary: | summary |