The following data is part of a premarket notification filed by Medtronic Navigation Israel, Ltd. with the FDA for Polestar, Model N-30.
| Device ID | K092308 |
| 510k Number | K092308 |
| Device Name: | POLESTAR, MODEL N-30 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDTRONIC NAVIGATION ISRAEL, LTD. KOCHAV YOKNEAM BLDG P.O. BOX 548 Yokneam Elit, IL 20692 |
| Contact | Yair Penias |
| Correspondent | Yair Penias MEDTRONIC NAVIGATION ISRAEL, LTD. KOCHAV YOKNEAM BLDG P.O. BOX 548 Yokneam Elit, IL 20692 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-30 |
| Decision Date | 2010-03-16 |
| Summary: | summary |