The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Models Hrk-63-8 Pms And Hrk-127-8 Knee Array Coils.
| Device ID | K033567 |
| 510k Number | K033567 |
| Device Name: | MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI DEVICES CORP. 1515 PARAMOUNT DR. Waukesha, WI 53186 |
| Contact | Thomas Schubert |
| Correspondent | Thomas 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 | 2003-11-10 |
| Decision Date | 2003-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086166 | K033567 | 000 |
| 00884838086128 | K033567 | 000 |
| 00884838066656 | K033567 | 000 |
| 00884838065826 | K033567 | 000 |
| 00884838065819 | K033567 | 000 |
| 00884838065802 | K033567 | 000 |
| 00884838065796 | K033567 | 000 |
| 00884838085541 | K033567 | 000 |
| 00884838085527 | K033567 | 000 |