AR-1000 AUTOMATIC REFRACTOR— 510(k) K861066

Substantially Equivalent

Nidek, Inc.

FDA 510(k) clearance K861066 for AR-1000 AUTOMATIC REFRACTOR, Substantially Equivalent on 1986-04-04. 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: 1986-03-20
Decision date: 1986-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, 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.