NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)— 510(k) K013694
Substantially EquivalentNidek, Inc.
FDA 510(k) clearance K013694 for NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS), Substantially Equivalent on 2002-11-19. Applicant: Nidek, Inc.. Device class: 2.
Clearance details
- Applicant
- Nidek, Inc.
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, CA, US
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