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FDA 510(k)

CIRRUS HD-OCT

K-Number: K181534 · 2019-02-15

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2019-02-15
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CIRRUS HD-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 2019-02-15 under 510(k) number K181534. 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 CIRRUS HD-OCT?

CIRRUS HD-OCT is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K181534.

When did CIRRUS HD-OCT receive FDA 510(k) clearance?

CIRRUS HD-OCT received FDA 510(k) clearance on 2019-02-15, under 510(k) number K181534.

Who is the listed applicant for CIRRUS HD-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 CIRRUS HD-OCT?

The FDA product code for CIRRUS HD-OCT is OBO.

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Other records listing Carl Zeiss Meditec, Inc. as applicant

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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.

K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey CorporationK250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbHK240924AnterionHeidelberg Engineering GmbHK241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH

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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