The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Model #qwh-63, Quadrature Wrist And Hand Coil.
| Device ID | K931008 |
| 510k Number | K931008 |
| Device Name: | MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRI DEVICES CORP. 1900 PEWAUKEE ROAD, SUITE N AIRPORT BUSINESS CENTER Waukesha, WI 53188 |
| Contact | Thomas Schubert |
| Correspondent | Thomas Schubert MRI DEVICES CORP. 1900 PEWAUKEE ROAD, SUITE N AIRPORT BUSINESS CENTER Waukesha, WI 53188 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-26 |
| Decision Date | 1993-06-18 |