NFC-600 Automated Portable Retinal Camera— 510(k) K210197

Name: FDA 510(k) clearance K210197
Creator: U.S. Food and Drug Administration
Published: 2021-04-13

Substantially Equivalent

Crystalvue Medical Corporation

FDA 510(k) clearance K210197 for NFC-600 Automated Portable Retinal Camera, Substantially Equivalent on 2021-04-13. 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: 2021-01-25
Decision date: 2021-04-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Taoyuan City, TW

Download summary PDF View on FDA.gov ↗

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