The following data is part of a premarket notification filed by Igc-medical Advances, Inc. with the FDA for Model 445si-64e Quadrature Wrist Coil.
| Device ID | K000589 |
| 510k Number | K000589 |
| Device Name: | MODEL 445SI-64E QUADRATURE WRIST COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | IGC-MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Contact | Thomas E Tynes |
| Correspondent | Thomas E Tynes IGC-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 | 2000-02-22 |
| Decision Date | 2000-03-14 |