The following data is part of a premarket notification filed by Resonance Innovations Llc with the FDA for 1.5t Pediatric Head And Spine Array Model.
| Device ID | K060689 |
| 510k Number | K060689 |
| Device Name: | 1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | RESONANCE INNOVATIONS LLC 12530 HARNEY CIRCLE Omaha, NE 68154 |
| Contact | Randall Jones |
| Correspondent | Randall Jones RESONANCE INNOVATIONS LLC 12530 HARNEY CIRCLE Omaha, NE 68154 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-15 |
| Decision Date | 2006-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859193006029 | K060689 | 000 |
| 00859193006012 | K060689 | 000 |