The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Hrw-63-int Wrist Array Coil.
| Device ID | K022588 |
| 510k Number | K022588 |
| Device Name: | HRW-63-INT WRIST ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Contact | Tom Schubert |
| Correspondent | Tom Schubert MRI DEVICES CORP. 1515 PARAMOUNT DR. 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 | 2002-08-05 |
| Decision Date | 2002-09-04 |