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FDA 510(k)

EXCELSIOR

K-Number: K130453 · 2013-04-02

ApplicantEyekor, LLC
Decision Date2013-04-02
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXCELSIOR is the device name listed in this FDA 510(k) record. The listed applicant is Eyekor, LLC. It received FDA 510(k) clearance on 2013-04-02 under 510(k) number K130453. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCELSIOR?

EXCELSIOR is a medical device that received FDA 510(k) clearance on 2013-04-02. The listed applicant is Eyekor, LLC. The 510(k) number is K130453.

When did EXCELSIOR receive FDA 510(k) clearance?

EXCELSIOR received FDA 510(k) clearance on 2013-04-02, under 510(k) number K130453.

Who is the listed applicant for EXCELSIOR?

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

What is the FDA product code for EXCELSIOR?

The FDA product code for EXCELSIOR is NFJ.

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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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