Neo
FDA 510(k) clearance K192889 · decided 2020-01-30
Clearance details
- K-number
- K192889
- Device name
- Neo
- Applicant
- Eemagine Medical Imaging Solutions GmbH
- Decision
- Substantially Equivalent
- Date received
- 2019-10-10
- Decision date
- 2020-01-30
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- OMA
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Berlin, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.