Fundus Camera— 510(k) K190954

Name: FDA 510(k) clearance K190954
Creator: U.S. Food and Drug Administration
Published: 2020-01-22

Substantially Equivalent

Chongqing Bio Newvision Medical Equipment , Ltd.

FDA 510(k) clearance K190954 for Fundus Camera, Substantially Equivalent on 2020-01-22. Applicant: Chongqing Bio Newvision Medical Equipment , Ltd.. Device class: 2.

Clearance details

Applicant: Chongqing Bio Newvision Medical Equipment , Ltd.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2019-04-11
Decision date: 2020-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chongqing, CN

Download summary PDF View on FDA.gov ↗

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