The following data is part of a premarket notification filed by Midwest R.f. Llc. with the FDA for Sv Dbs Brain Array, Model 1500sv-sms64.
| Device ID | K090267 |
| 510k Number | K090267 |
| Device Name: | SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64 |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MIDWEST R.F. LLC. 1015 WALNUT RIDGE DRIVE PO BOX 348 Hartland, WI 53029 |
| Contact | David M Peterson |
| Correspondent | David M Peterson MIDWEST R.F. LLC. 1015 WALNUT RIDGE DRIVE PO BOX 348 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 | 2009-02-03 |
| Decision Date | 2009-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850359007056 | K090267 | 000 |
| 08503590070566 | K090267 | 000 |
| 00850359007560 | K090267 | 000 |