The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Qwh-085 Wrist Array Coil.
| Device ID | K993235 |
| 510k Number | K993235 |
| Device Name: | QWH-085 WRIST ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI DEVICES CORP. N8 W22520 JOHNSON DR., UNIT K JOHNSON DR., CORPORATE CENTER Waukesha, WI 53186 |
| Contact | Thomas Schubert |
| Correspondent | Thomas Schubert MRI DEVICES CORP. N8 W22520 JOHNSON DR., UNIT K JOHNSON DR., CORPORATE CENTER Waukesha, WI 53186 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-27 |
| Decision Date | 1999-10-15 |