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FDA 510(k)

NIDEK KM-1000 SURGICAL KERATOMETER

K-Number: K862137 · 1986-07-23

ApplicantNidek, Inc.
Decision Date1986-07-23
Product CodeHLQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK KM-1000 SURGICAL KERATOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1986-07-23 under 510(k) number K862137. The device is classified under product code HLQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK KM-1000 SURGICAL KERATOMETER?

NIDEK KM-1000 SURGICAL KERATOMETER is a medical device that received FDA 510(k) clearance on 1986-07-23. The listed applicant is Nidek, Inc.. The 510(k) number is K862137.

When did NIDEK KM-1000 SURGICAL KERATOMETER receive FDA 510(k) clearance?

NIDEK KM-1000 SURGICAL KERATOMETER received FDA 510(k) clearance on 1986-07-23, under 510(k) number K862137.

Who is the listed applicant for NIDEK KM-1000 SURGICAL KERATOMETER?

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 KM-1000 SURGICAL KERATOMETER?

The FDA product code for NIDEK KM-1000 SURGICAL KERATOMETER is HLQ.

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Other records listing Nidek, Inc. as applicant

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.

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: HLQ)

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.

K003299OPD-SCAN, MODELS ARK-10000 AND ARK-9000Nidek Co., Ltd.K973756EYE SYS VISTAEyesys Technologies, Inc.K964290EYECHEKReichert Ophthalmic Instruments, Div. Leica, Inc.K945382TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETERExpertech Assoc., Inc.K944207TOPOGRAPHIC MODELING SYSTEM 2 TMS-2Computed Anatomy, Inc.K944616KERATRON CORNEAL TOPOGRAPHERAlliance Medical Marketinig

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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