FDA 510(k)

Excelsior

K-Number: K220929 · 2022-10-31

Decision Date2022-10-31

Product CodeNFJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Excelsior is the device name listed in this FDA 510(k) record. The listed applicant is Merit Cro, Inc.. It received FDA 510(k) clearance on 2022-10-31 under 510(k) number K220929. 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 2022-10-31. The listed applicant is Merit Cro, Inc.. The 510(k) number is K220929.

When did Excelsior receive FDA 510(k) clearance?

Excelsior received FDA 510(k) clearance on 2022-10-31, under 510(k) number K220929.

Who is the listed applicant for Excelsior?

The FDA 510(k) record lists Merit Cro, Inc. 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.

Related Devices (Code: NFJ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.