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FDA 510(k)

MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD

K-Number: K093308 · 2010-01-14

ApplicantNidek Medical Products, Inc.
Decision Date2010-01-14
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 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 2010-01-14 under 510(k) number K093308. 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 8 OCSI, MARK 5 NUVO 8 STD?

MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD is a medical device that received FDA 510(k) clearance on 2010-01-14. The listed applicant is Nidek Medical Products, Inc.. The 510(k) number is K093308.

When did MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD receive FDA 510(k) clearance?

MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD received FDA 510(k) clearance on 2010-01-14, under 510(k) number K093308.

Who is the listed applicant for MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 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 8 OCSI, MARK 5 NUVO 8 STD?

The FDA product code for MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 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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