The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Model 205ge-64: Pathway Mri Carotid Array Coil.
| Device ID | K003144 |
| 510k Number | K003144 |
| Device Name: | MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| 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 | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2000-12-13 |