The following data is part of a premarket notification filed by Mri Devices Corporation with the FDA for Hrk-123 Knee Array Coil.
| Device ID | K050299 |
| 510k Number | K050299 |
| Device Name: | HRK-123 KNEE ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI DEVICES CORPORATION N27W23676 PAUL RD Pewaukee, WI 53072 |
| Contact | Tom Schubert |
| Correspondent | Tom 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 | 2005-02-07 |
| Decision Date | 2005-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838065437 | K050299 | 000 |
| 00884838065420 | K050299 | 000 |