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FDA 510(k)

ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM

K-Number: K991284 · 1999-08-06

ApplicantNidek, Inc.
Decision Date1999-08-06
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1999-08-06 under 510(k) number K991284. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM?

ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-06. The listed applicant is Nidek, Inc.. The 510(k) number is K991284.

When did ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM receive FDA 510(k) clearance?

ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM received FDA 510(k) clearance on 1999-08-06, under 510(k) number K991284.

Who is the listed applicant for ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM?

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 ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM?

The FDA product code for ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM is MXK.

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Other records listing Nidek, Inc. as applicant

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K050336OPD-STATION SOFTWAREK042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300K031733NON-CONTACT TONOMETER, MODEL NT-4000K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000K013694NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)K020876ECHOSCAN, MODEL US-1800

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Related Devices (Code: MXK)

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.

K251848Pentacam® Cornea OCTOculus Optikgeräte GmbHK252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey CorporationK223700BOSS™Intelon Optics, Inc.K222933MYAHVisia Imaging S.R.L.K211868MYAHVisia Imaging S.R.L.K202989Myopia MasterOculus Optikgeräte GmbH

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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