The following data is part of a premarket notification filed by Mri Devices Corporation with the FDA for Nva-63-8-a And Nva-63-16-a Neurovascular Array Coil.
| Device ID | K042103 |
| 510k Number | K042103 |
| Device Name: | NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MRI DEVICES CORPORATION 1515 PARAMOUNT DRIVE Waukesha, WI 53186 |
| Contact | Tom Schubert |
| Correspondent | Tom Schubert MRI DEVICES CORPORATION 1515 PARAMOUNT DRIVE 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 | 2004-08-04 |
| Decision Date | 2004-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838067165 | K042103 | 000 |
| 00884838067158 | K042103 | 000 |