The following data is part of a premarket notification filed by Alpha Omega Ltd. with the FDA for Neurodrive System.
| Device ID | K051830 |
| 510k Number | K051830 |
| Device Name: | NEURODRIVE SYSTEM |
| Classification | Electrode, Depth |
| Applicant | ALPHA OMEGA LTD. HA'AVODA ST., P.O. BOX 810 Nazareth Illit, IL 17105 |
| Contact | Shlomo Pundak |
| Correspondent | Shlomo Pundak 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 | 2005-07-06 |
| Decision Date | 2005-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290016450242 | K051830 | 000 |
| 07290114064156 | K051830 | 000 |
| 27290114064082 | K051830 | 000 |
| 27290114064099 | K051830 | 000 |
| 27290114064105 | K051830 | 000 |
| 27290114064112 | K051830 | 000 |
| 27290114061166 | K051830 | 000 |
| 27290114061104 | K051830 | 000 |
| 27290114061111 | K051830 | 000 |
| 27290114061128 | K051830 | 000 |
| 27290114061135 | K051830 | 000 |
| 27290114061142 | K051830 | 000 |
| 27290114061159 | K051830 | 000 |
| 07290114064149 | K051830 | 000 |