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FDA 510(k)

NIDEK ADC-8000 LASER SYSTEM

K-Number: K872846 · 1987-10-15

ApplicantNidek, Inc.
Decision Date1987-10-15
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK ADC-8000 LASER 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 1987-10-15 under 510(k) number K872846. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK ADC-8000 LASER SYSTEM?

NIDEK ADC-8000 LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1987-10-15. The listed applicant is Nidek, Inc.. The 510(k) number is K872846.

When did NIDEK ADC-8000 LASER SYSTEM receive FDA 510(k) clearance?

NIDEK ADC-8000 LASER SYSTEM received FDA 510(k) clearance on 1987-10-15, under 510(k) number K872846.

Who is the listed applicant for NIDEK ADC-8000 LASER 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 NIDEK ADC-8000 LASER SYSTEM?

The FDA product code for NIDEK ADC-8000 LASER SYSTEM is HQF.

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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: HQF)

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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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