The following data is part of a premarket notification filed by Odin Medical Technologies Ltd. with the FDA for Polestar N-20.
| Device ID | K032541 |
| 510k Number | K032541 |
| Device Name: | POLESTAR N-20 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ODIN MEDICAL TECHNOLOGIES LTD. P.O BOX 548 Yokneam Elit, IL 20692 |
| Contact | Einav Shlomovitz |
| Correspondent | Einav Shlomovitz ODIN MEDICAL TECHNOLOGIES LTD. P.O BOX 548 Yokneam Elit, IL 20692 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-18 |
| Decision Date | 2003-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994670083 | K032541 | 000 |
| 00613994316301 | K032541 | 000 |
| 00613994316295 | K032541 | 000 |
| 00613994316288 | K032541 | 000 |
| 00613994316271 | K032541 | 000 |
| 00613994316264 | K032541 | 000 |
| 00613994209658 | K032541 | 000 |
| 00643169351745 | K032541 | 000 |
| 00885074361505 | K032541 | 000 |
| 20613994728535 | K032541 | 000 |
| 00613994316318 | K032541 | 000 |
| 00613994423955 | K032541 | 000 |
| 00613994463067 | K032541 | 000 |
| 00613994670069 | K032541 | 000 |
| 00613994670052 | K032541 | 000 |
| 00613994532107 | K032541 | 000 |
| 00613994532091 | K032541 | 000 |
| 00613994532053 | K032541 | 000 |
| 00613994532046 | K032541 | 000 |
| 00613994532039 | K032541 | 000 |
| 00613994532022 | K032541 | 000 |
| 00613994505002 | K032541 | 000 |
| 00613994728531 | K032541 | 000 |