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FDA 510(k)

NIDEK MODEL NT-1000

K-Number: K913189 · 1991-10-15

ApplicantNidek, Inc.
Decision Date1991-10-15
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK MODEL NT-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1991-10-15 under 510(k) number K913189. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK MODEL NT-1000?

NIDEK MODEL NT-1000 is a medical device that received FDA 510(k) clearance on 1991-10-15. The listed applicant is Nidek, Inc.. The 510(k) number is K913189.

When did NIDEK MODEL NT-1000 receive FDA 510(k) clearance?

NIDEK MODEL NT-1000 received FDA 510(k) clearance on 1991-10-15, under 510(k) number K913189.

Who is the listed applicant for NIDEK MODEL NT-1000?

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 MODEL NT-1000?

The FDA product code for NIDEK MODEL NT-1000 is HKX.

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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: HKX)

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.

K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATopcon CorporationK223739VS Tabletop TonometerMedimaging Integrated Solution, Inc.K190382Intraocular Pressure Tonometer EASYTONCompany ElamedK181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis)K181143Keeler TonoCare TonometerKeeler Instruments, Inc.K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation

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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