The following data is part of a premarket notification filed by Alpha Omega Ltd. with the FDA for Neuronav System And Neuronav Drive.
| Device ID | K071697 |
| 510k Number | K071697 |
| Device Name: | NEURONAV SYSTEM AND NEURONAV DRIVE |
| Classification | Electrode, Depth |
| Applicant | ALPHA OMEGA LTD. HA'AVODA ST., P.O. BOX 810 Nazareth Illit, IL 17105 |
| Contact | Baheej Danial |
| Correspondent | Baheej Danial ALPHA OMEGA LTD. HA'AVODA ST., P.O. BOX 810 Nazareth Illit, IL 17105 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-20 |
| Decision Date | 2007-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290014954939 | K071697 | 000 |
| 17290014954110 | K071697 | 000 |
| 07290014954069 | K071697 | 000 |
| 07290014954052 | K071697 | 000 |