Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K120098
STERILE DISPOSABLES FOR MER · Alpha Omega Engineering , Ltd. · decided 2012-06-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Sterile cannula | Sterile cannula | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114062121 |
| Sterile neuroprobe | Non-Shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114061902 |
| NeuroProbe | MF-Shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290014954540 |
| Cannula | Standard | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114060998 |
| Sterile electrode's cable | Sterile electrode's cable | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114060929 |
| NeuroProbe | Shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290014954328 |
| Sterile neuroprobe | Shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114061858 |
| Sterile neuroprobe | Shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114061933 |
| Sterile electrode's cable | Sterile electrode's cable | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114061674 |
| Sterile electrode's cable | Sterile electrode's cable | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114061605 |
| Sterile cannula | Sterile cannula | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114062220 |
| NeuroProbe | NeuroProbe | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290014954946 |
| Sterile electrode's cable | Sterile electrode's cable | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114064194 |
| Cannula | Standard | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114061094 |
| NeuroProbe | Non-shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290014954458 |
| Sterile neuroprobe | Non-Shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114062008 |
| NeuroProbe | MF-Shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290014954564 |
| Sterile electrode's cable | Sterile electrode's cable | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114064286 |
| Sterile neuroprobe | Non-Shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114061537 |
| Cannula | Standard | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114061018 |
| NeuroProbe | Shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290014954403 |
| Sterile cannula | Sterile cannula | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114062053 |
| NeuroNav Input Cable | 1 channel MER only | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290014954168 |
| Sterile neuroprobe | Non-Shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290114061865 |
| NeuroProbe | Non-shielded | ALPHA OMEGA ENGINEERING CO. LTD. | GZL | 07290014954489 |