The following data is part of a premarket notification filed by Mri Devices Corporation with the FDA for Hrw-63-8 Wrist Array Coil; Hrw-127-8 Wrist Array Coil.
| Device ID | K050622 |
| 510k Number | K050622 |
| Device Name: | HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI DEVICES CORPORATION N27W23676 PAUL RD Pewaukee, WI 53072 |
| Contact | Thomas Schubert |
| Correspondent | Thomas Schubert MRI DEVICES CORPORATION N27W23676 PAUL RD Pewaukee, WI 53072 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-10 |
| Decision Date | 2005-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838087316 | K050622 | 000 |
| 00884838065680 | K050622 | 000 |
| 00884838066380 | K050622 | 000 |
| 00884838066458 | K050622 | 000 |
| 00884838066502 | K050622 | 000 |
| 00884838066526 | K050622 | 000 |
| 00884838066533 | K050622 | 000 |
| 00884838066663 | K050622 | 000 |
| 00884838066670 | K050622 | 000 |
| 00884838066748 | K050622 | 000 |
| 00884838067028 | K050622 | 000 |
| 00884838067189 | K050622 | 000 |
| 00884838067219 | K050622 | 000 |
| 00884838067240 | K050622 | 000 |
| 00884838086135 | K050622 | 000 |
| 00884838086203 | K050622 | 000 |
| 00884838087231 | K050622 | 000 |
| 00884838065673 | K050622 | 000 |