NIDEK RS-3000— 510(k) K121622

Substantially Equivalent

Nidek Co., Ltd.

FDA 510(k) clearance K121622 for NIDEK RS-3000, Substantially Equivalent on 2013-03-14. Applicant: Nidek Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2012-06-01
Decision date: 2013-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wadsworth, OH, 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.