OVision Imaging System— 510(k) K200275

Substantially Equivalent

Ophthalmic Labs, Inc.

FDA 510(k) clearance K200275 for OVision Imaging System, Substantially Equivalent on 2020-03-03. Applicant: Ophthalmic Labs, Inc..

Clearance details

Applicant: Ophthalmic Labs, Inc.
Product code: Code NFJ
Advisory panel: Radiology
Date received: 2020-02-04
Decision date: 2020-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milton, MA, US

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