Nexxis OR
FDA 510(k) clearance K173381 · decided 2018-02-22
Clearance details
- K-number
- K173381
- Device name
- Nexxis OR
- Applicant
- Barco N.V.
- Decision
- Substantially Equivalent
- Date received
- 2017-10-30
- Decision date
- 2018-02-22
- Days to decision
- 115 days
- Clearance type
- Special
- Product code
- DXJ
- Device class
- 2
- Regulation number
- 870.2450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Kortrijk, BE
- Third-party review
- No
- Expedited review
- No
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