FDA 510(k)

P200TE (A10700)

K-Number: K231673 · 2023-08-18

Decision Date2023-08-18

Product CodeOBO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

P200TE (A10700) is a medical device manufactured by Optos Plc.. It received FDA 510(k) clearance on 2023-08-18 under approval number K231673. 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 (A10700)?

P200TE (A10700) is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Optos Plc.. The 510(k) number is K231673.

When was P200TE (A10700) approved by the FDA?

P200TE (A10700) received FDA 510(k) clearance on 2023-08-18, under approval number K231673.

What company makes P200TE (A10700)?

P200TE (A10700) is manufactured by Optos Plc..

What is the FDA product code for P200TE (A10700)?

The FDA product code for P200TE (A10700) is OBO.

Other Devices by Optos Plc.

K162039OptosAdvance 4.0 Software K173707P200TE K190732P200TxE 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.