The following data is part of a premarket notification filed by Midwest R.f. Llc. with the FDA for Model 6900ge-64: C-spine Array.
| Device ID | K002860 |
| 510k Number | K002860 |
| Device Name: | MODEL 6900GE-64: C-SPINE ARRAY |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MIDWEST R.F. LLC. 535 NORTON DR. Hartland, WI 53029 |
| Contact | Ralph S Hashoian |
| Correspondent | Ralph S Hashoian MIDWEST R.F. LLC. 535 NORTON DR. Hartland, WI 53029 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-13 |
| Decision Date | 2000-11-22 |