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FDA 510(k)

SPECTRAL OCT/SLO

K-Number: K080460 · 2008-11-14

ApplicantOpko Health, Inc.
Decision Date2008-11-14
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTRAL OCT/SLO is the device name listed in this FDA 510(k) record. The listed applicant is Opko Health, Inc.. It received FDA 510(k) clearance on 2008-11-14 under 510(k) number K080460. 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 SPECTRAL OCT/SLO?

SPECTRAL OCT/SLO is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is Opko Health, Inc.. The 510(k) number is K080460.

When did SPECTRAL OCT/SLO receive FDA 510(k) clearance?

SPECTRAL OCT/SLO received FDA 510(k) clearance on 2008-11-14, under 510(k) number K080460.

Who is the listed applicant for SPECTRAL OCT/SLO?

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

What is the FDA product code for SPECTRAL OCT/SLO?

The FDA product code for SPECTRAL OCT/SLO 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.

K261019ANTERIONHeidelberg Engineering GmbHK253837SPECTRALIS 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 GmbH

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.

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