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FDA 510(k)

P200TE

K-Number: K173707 · 2018-02-28

ApplicantOptos Plc.
Decision Date2018-02-28
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

P200TE is a medical device manufactured by Optos Plc.. It received FDA 510(k) clearance on 2018-02-28 under approval number K173707. 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 P200TE?

P200TE is a medical device that received FDA 510(k) clearance on 2018-02-28. It is manufactured by Optos Plc.. The 510(k) number is K173707.

When was P200TE approved by the FDA?

P200TE received FDA 510(k) clearance on 2018-02-28, under approval number K173707.

What company makes P200TE?

P200TE is manufactured by Optos Plc..

What is the FDA product code for P200TE?

The FDA product code for P200TE is OBO.

Other Devices by Optos Plc.

K162039OptosAdvance 4.0 Software K190732P200TxE K231673P200TE (A10700) K233602P200TE (A10700)

Related Devices (Code: OBO)

K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc. K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. K1615093D OCT-1 MaestroTopcon Corporation K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorHeidelberg Engineering GmbH K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorHeidelberg Engineering GmbH K163195PRIMUSCarl Zeiss Suzhou Co., Ltd.

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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