NIDEK HANDY— 510(k) K973218
Substantially EquivalentNidek, Inc.
FDA 510(k) clearance K973218 for NIDEK HANDY, Substantially Equivalent on 1997-11-04. Applicant: Nidek, Inc.. Device class: 2.
Clearance details
- Applicant
- Nidek, Inc.
- Product code
- Code HKI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
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