The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Model 405ge-64: Phased Array Tmj Coil.
| Device ID | K944773 |
| 510k Number | K944773 |
| Device Name: | MODEL 405GE-64: PHASED ARRAY TMJ COIL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Contact | Thomas E Tynes |
| Correspondent | Thomas E Tynes MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1995-01-25 |