FDA 510(k)

OptikView GUP2103CMI

K-Number: K191705 · 2020-03-16

Decision Date2020-03-16

Product CodePGY

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OptikView GUP2103CMI is a medical device manufactured by The Linden Group Corp. It received FDA 510(k) clearance on 2020-03-16 under approval number K191705. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptikView GUP2103CMI?

OptikView GUP2103CMI is a medical device that received FDA 510(k) clearance on 2020-03-16. It is manufactured by The Linden Group Corp. The 510(k) number is K191705.

When was OptikView GUP2103CMI approved by the FDA?

OptikView GUP2103CMI received FDA 510(k) clearance on 2020-03-16, under approval number K191705.

What company makes OptikView GUP2103CMI?

OptikView GUP2103CMI is manufactured by The Linden Group Corp.

What is the FDA product code for OptikView GUP2103CMI?

The FDA product code for OptikView GUP2103CMI is PGY.

Other Devices by The Linden Group Corp

K160328DIVA ZSP2105CMI with QUBYX PerfectLum bundle

Related Devices (Code: PGY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.