The following data is part of a premarket notification filed by Midwest R.f. Llc. with the FDA for Special Procedures Head Coil; Model # 1100ge-64.
| Device ID | K003386 |
| 510k Number | K003386 |
| Device Name: | SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MIDWEST R.F. LLC. 535 NORTON DR. P.O. BOX 350 Hartland, WI 53029 |
| Contact | Ralph S Hashoian |
| Correspondent | Ralph S Hashoian MIDWEST R.F. LLC. 535 NORTON DR. P.O. BOX 350 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 | 2000-10-31 |
| Decision Date | 2000-12-28 |