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FDA 510(k)

NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)

K-Number: K013694 · 2002-11-19

ApplicantNidek, Inc.
Decision Date2002-11-19
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 2002-11-19 under 510(k) number K013694. 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 NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)?

NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) is a medical device that received FDA 510(k) clearance on 2002-11-19. The listed applicant is Nidek, Inc.. The 510(k) number is K013694.

When did NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) receive FDA 510(k) clearance?

NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) received FDA 510(k) clearance on 2002-11-19, under 510(k) number K013694.

Who is the listed applicant for NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)?

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

What is the FDA product code for NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)?

The FDA product code for NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) is NFJ.

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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

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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