The following data is part of a premarket notification filed by Alpha Omega Ltd. with the FDA for Neurotrek Physiological Navigation System For Neurosurgery.
| Device ID | K993622 |
| 510k Number | K993622 |
| Device Name: | NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY |
| Classification | Electrode, Depth |
| Applicant | ALPHA OMEGA LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Contact | Shoshana S Friedmn |
| Correspondent | Shoshana S Friedmn ALPHA OMEGA LTD. 117 AHUZAH ST. Ra'ananna, IL 43373 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-26 |
| Decision Date | 2000-01-24 |
| Summary: | summary |