The following data is part of a premarket notification filed by Mri Devices Corporation with the FDA for Models Fac-63 And Fac-127 Foot And Ankle Coils.
| Device ID | K050514 |
| 510k Number | K050514 |
| Device Name: | MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI DEVICES CORPORATION N27 W23676 PAUL RD Pewaukee, WI 53072 |
| Contact | Thomas Schubert |
| Correspondent | Thomas Schubert MRI DEVICES CORPORATION N27 W23676 PAUL RD Pewaukee, WI 53072 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-01 |
| Decision Date | 2005-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086227 | K050514 | 000 |
| 00884838066021 | K050514 | 000 |
| 00884838066038 | K050514 | 000 |
| 00884838066045 | K050514 | 000 |
| 00884838066052 | K050514 | 000 |
| 00884838066069 | K050514 | 000 |
| 00884838066076 | K050514 | 000 |
| 00884838066083 | K050514 | 000 |
| 00884838066090 | K050514 | 000 |
| 00884838066311 | K050514 | 000 |
| 00884838066342 | K050514 | 000 |
| 00884838066519 | K050514 | 000 |
| 00884838066632 | K050514 | 000 |
| 00884838066731 | K050514 | 000 |
| 00884838067103 | K050514 | 000 |
| 00884838067196 | K050514 | 000 |
| 00884838086142 | K050514 | 000 |
| 00884838066014 | K050514 | 000 |