The following data is part of a premarket notification filed by Resonance Innovations Llc with the FDA for 1.5t Orbit And Mandible Array, 3.0t Orbit And Mandible Array.
| Device ID | K133986 |
| 510k Number | K133986 |
| Device Name: | 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | RESONANCE INNOVATIONS LLC 9840 S 140th St Ste 8 Omaha, NE 68138 |
| Contact | Randall Jones |
| Correspondent | Randall Jones RESONANCE INNOVATIONS LLC 9840 S 140th St Ste 8 Omaha, NE 68138 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-26 |
| Decision Date | 2014-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859193006579 | K133986 | 000 |