AUTO REFRACTOMETER— 510(k) K831083

Substantially Equivalent

Nidek, Inc.

FDA 510(k) clearance K831083 for AUTO REFRACTOMETER, Substantially Equivalent on 1983-06-10. Applicant: Nidek, Inc.. Device class: 1.

Clearance details

Applicant: Nidek, Inc.
Product code: Code HKO
Device class: Class 1
Regulation: 21 CFR 886.1760
Advisory panel: Ophthalmic
Date received: 1983-04-04
Decision date: 1983-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.