The following data is part of a premarket notification filed by Resonance Innovations Llc with the FDA for St Sense Nv 8 Array Coil.
| Device ID | K140282 |
| 510k Number | K140282 |
| Device Name: | ST SENSE NV 8 ARRAY 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 | 2014-02-04 |
| Decision Date | 2014-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859193006326 | K140282 | 000 |