The following data is part of a premarket notification filed by Resonance Innovations Llc with the FDA for Siemens 3.0 Blanket Array Coil.
| Device ID | K142755 |
| 510k Number | K142755 |
| Device Name: | Siemens 3.0 Blanket Array Coil |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | RESONANCE INNOVATIONS LLC 9840 S. 140TH ST., STE 8 Omaha, NE 68138 |
| Contact | Randall Jones |
| Correspondent | Brian Carter 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 | 2014-09-25 |
| Decision Date | 2014-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859193006463 | K142755 | 000 |
| 00859193006180 | K142755 | 000 |
| 00859193006173 | K142755 | 000 |
| 00859193006166 | K142755 | 000 |
| 00859193006159 | K142755 | 000 |