The following data is part of a premarket notification filed by Resonance Innovations Llc with the FDA for 3t Distal Coil, 3t Elbow Coil, 3t Long Bone Coil.
| Device ID | K130457 |
| 510k Number | K130457 |
| Device Name: | 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-22 |
| Decision Date | 2013-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859193006432 | K130457 | 000 |
| 00859193006234 | K130457 | 000 |
| 00859193006227 | K130457 | 000 |
| 00859193006104 | K130457 | 000 |
| 00859193006098 | K130457 | 000 |
| 00859193006081 | K130457 | 000 |
| 00859193006074 | K130457 | 000 |
| 00859193006067 | K130457 | 000 |
| 00859193006050 | K130457 | 000 |
| 00859193006043 | K130457 | 000 |
| 00859193006241 | K130457 | 000 |
| 00859193006258 | K130457 | 000 |
| 00859193006265 | K130457 | 000 |
| 00859193006364 | K130457 | 000 |
| 00859193006357 | K130457 | 000 |
| 00859193006340 | K130457 | 000 |
| 00859193006333 | K130457 | 000 |
| 00859193006319 | K130457 | 000 |
| 00859193006302 | K130457 | 000 |
| 00859193006296 | K130457 | 000 |
| 00859193006289 | K130457 | 000 |
| 00859193006272 | K130457 | 000 |
| 00859193006036 | K130457 | 000 |