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FDA 510(k)

NIDEK DIGITAL KERATOMETER

K-Number: K842892 · 1984-10-05

ApplicantNidek, Inc.
Decision Date1984-10-05
Product CodeHQL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK DIGITAL 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 1984-10-05 under 510(k) number K842892. The device is classified under product code HQL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK DIGITAL KERATOMETER?

NIDEK DIGITAL KERATOMETER is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is Nidek, Inc.. The 510(k) number is K842892.

When did NIDEK DIGITAL KERATOMETER receive FDA 510(k) clearance?

NIDEK DIGITAL KERATOMETER received FDA 510(k) clearance on 1984-10-05, under 510(k) number K842892.

Who is the listed applicant for NIDEK DIGITAL 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 DIGITAL KERATOMETER?

The FDA product code for NIDEK DIGITAL KERATOMETER is HQL.

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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: HQL)

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.

K914311CHIROFLEX II LENS MICROSERT(TM)Chiron OphthalmicsK913626SOFTRANS INJECTORStaar Surgical Co.K842504AMER. MEDICAL OPTICS DIGITAL KERATO-American Medical OpticsK771933CILCO ANTERIOR CHAMBER LENSCalifornia Intraocular Lens

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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