Fundus Camera— 510(k) K190954

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..

Clearance details

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

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