OVision Imaging System
K-Number: K200275 · 2020-03-03
ApplicantOphthalmic Labs, Inc.
Decision Date2020-03-03
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OVision Imaging System is a medical device manufactured by Ophthalmic Labs, Inc.. It received FDA 510(k) clearance on 2020-03-03 under approval number K200275. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OVision Imaging System?
OVision Imaging System is a medical device that received FDA 510(k) clearance on 2020-03-03. It is manufactured by Ophthalmic Labs, Inc.. The 510(k) number is K200275.
When was OVision Imaging System approved by the FDA?
OVision Imaging System received FDA 510(k) clearance on 2020-03-03, under approval number K200275.
What company makes OVision Imaging System?
OVision Imaging System is manufactured by Ophthalmic Labs, Inc..
What is the FDA product code for OVision Imaging System?
The FDA product code for OVision Imaging System is NFJ.
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Official Source
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