ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM— 510(k) K991284
Substantially EquivalentNidek, Inc.
FDA 510(k) clearance K991284 for ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM, Substantially Equivalent on 1999-08-06. Applicant: Nidek, Inc.. Device class: 2.
Clearance details
- Applicant
- Nidek, Inc.
- Product code
- Code MXK
- Device class
- Class 2
- Regulation
- 21 CFR 886.1850
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
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