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FDA 510(k)

PLEX Elite 9000 SS-OCT

K-Number: K161194 · 2016-10-26

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2016-10-26
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PLEX Elite 9000 SS-OCT is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2016-10-26 under 510(k) 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. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K161194.

When did PLEX Elite 9000 SS-OCT receive FDA 510(k) clearance?

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

Who is the listed applicant for PLEX Elite 9000 SS-OCT?

The FDA 510(k) record lists Carl Zeiss Meditec, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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