The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Model 311ge-64: Whole Volume Neck Coil.
| Device ID | K914535 |
| 510k Number | K914535 |
| Device Name: | MODEL 311GE-64: WHOLE VOLUME NECK COIL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDICAL ADVANCES, INC. 10431 W. WATERTOWN PLANK RD. P.O. BOX 26425 Milwaukee, WI 53226 -0425 |
| Contact | Thomas Tynes |
| Correspondent | Thomas Tynes MEDICAL ADVANCES, INC. 10431 W. WATERTOWN PLANK RD. P.O. BOX 26425 Milwaukee, WI 53226 -0425 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-11 |
| Decision Date | 1991-11-27 |