Neuro Omega System
FDA 510(k) clearance K171581 · decided 2017-12-22
Clearance details
- K-number
- K171581
- Device name
- Neuro Omega System
- Applicant
- Alpha Omega Engineering , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-05-31
- Decision date
- 2017-12-22
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- GZL
- Device class
- 2
- Regulation number
- 882.1330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Nazareth, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use recall (Z-1216-2019) | Alpha Omega Engineering | 2019-05-06 |