The following data is part of a premarket notification filed by Midwest Rf, Llc with the FDA for Sv Dbs Vrain Array.
| Device ID | K111259 |
| 510k Number | K111259 |
| Device Name: | SV DBS VRAIN ARRAY |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MIDWEST RF, LLC P.O. BOX 348 1015 WALNUT RIDGE DRIVE Hartland, WI 53029 |
| Contact | Helmut Keidi |
| Correspondent | Helmut Keidi MIDWEST RF, LLC P.O. BOX 348 1015 WALNUT RIDGE DRIVE Hartland, WI 53029 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-04 |
| Decision Date | 2011-07-05 |