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FDA 510(k)

NIDEK CV-4000

K-Number: K880929 · 1988-05-25

ApplicantNidek, Inc.
Decision Date1988-05-25
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK CV-4000 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1988-05-25 under 510(k) number K880929. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK CV-4000?

NIDEK CV-4000 is a medical device that received FDA 510(k) clearance on 1988-05-25. The listed applicant is Nidek, Inc.. The 510(k) number is K880929.

When did NIDEK CV-4000 receive FDA 510(k) clearance?

NIDEK CV-4000 received FDA 510(k) clearance on 1988-05-25, under 510(k) number K880929.

Who is the listed applicant for NIDEK CV-4000?

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 CV-4000?

The FDA product code for NIDEK CV-4000 is HQE.

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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: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, Inc.

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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