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FDA 510(k)

MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD

K-Number: K123738 · 2013-02-28

ApplicantNidek Medical Products, Inc.
Decision Date2013-02-28
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Medical Products, Inc.. It received FDA 510(k) clearance on 2013-02-28 under 510(k) number K123738. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD?

MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD is a medical device that received FDA 510(k) clearance on 2013-02-28. The listed applicant is Nidek Medical Products, Inc.. The 510(k) number is K123738.

When did MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD receive FDA 510(k) clearance?

MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD received FDA 510(k) clearance on 2013-02-28, under 510(k) number K123738.

Who is the listed applicant for MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD?

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

What is the FDA product code for MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD?

The FDA product code for MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD is CAW.

Other records listing Nidek Medical Products, Inc. as applicant

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Related Devices (Code: CAW)

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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