FDA 510(k)

PLEX Elite 9000 SS-OCT

K-Number: K161194 · 2016-10-26

Decision Date2016-10-26

Product CodeOBO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PLEX Elite 9000 SS-OCT is a medical device manufactured by Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2016-10-26 under approval number K161194. 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 PLEX Elite 9000 SS-OCT?

PLEX Elite 9000 SS-OCT is a medical device that received FDA 510(k) clearance on 2016-10-26. It is manufactured by Carl Zeiss Meditec, Inc.. The 510(k) number is K161194.

When was PLEX Elite 9000 SS-OCT approved by the FDA?

PLEX Elite 9000 SS-OCT received FDA 510(k) clearance on 2016-10-26, under approval number K161194.

What company makes PLEX Elite 9000 SS-OCT?

PLEX Elite 9000 SS-OCT is manufactured by Carl Zeiss Meditec, Inc..

What is the FDA product code for PLEX Elite 9000 SS-OCT?

The FDA product code for PLEX Elite 9000 SS-OCT is OBO.

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Related Devices (Code: OBO)

K162783EnFocus 2300, EnFocus 4400Bioptigen, 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. K163475iVueOptovue, Inc.

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.