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FDA 510(k)

P200TxE

K-Number: K190732 · 2019-07-31

ApplicantOptos Plc.
Decision Date2019-07-31
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

P200TxE is a medical device manufactured by Optos Plc.. It received FDA 510(k) clearance on 2019-07-31 under approval number K190732. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P200TxE?

P200TxE is a medical device that received FDA 510(k) clearance on 2019-07-31. It is manufactured by Optos Plc.. The 510(k) number is K190732.

When was P200TxE approved by the FDA?

P200TxE received FDA 510(k) clearance on 2019-07-31, under approval number K190732.

What company makes P200TxE?

P200TxE is manufactured by Optos Plc..

What is the FDA product code for P200TxE?

The FDA product code for P200TxE is OBO.

Other Devices by Optos Plc.

K162039OptosAdvance 4.0 Software K173707P200TE K231673P200TE (A10700) K233602P200TE (A10700)

Related Devices (Code: OBO)

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Official Source

View on FDA Database →

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

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