SLIT LAMP SL-2000— 510(k) K163564

Substantially Equivalent

Nidek Co., Ltd.

FDA 510(k) clearance K163564 for SLIT LAMP SL-2000, Substantially Equivalent on 2017-05-19. Applicant: Nidek Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2016-12-19
Decision date: 2017-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gamagori, JP

Download summary PDF View on FDA.gov ↗

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