NFC-700 non-mydriatic auto fundus camera— 510(k) K182199

Name: FDA 510(k) clearance K182199
Creator: U.S. Food and Drug Administration
Published: 2019-01-02

Substantially Equivalent

Crystalvue Medical Corporation

FDA 510(k) clearance K182199 for NFC-700 non-mydriatic auto fundus camera, Substantially Equivalent on 2019-01-02. Applicant: Crystalvue Medical Corporation. Device class: 2.

Clearance details

Applicant: Crystalvue Medical Corporation
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2018-08-14
Decision date: 2019-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan City, TW

Download summary PDF View on FDA.gov ↗

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