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FDA 510(k)

NIDEK MODEL ADC-8000

K-Number: K894709 · 1989-10-04

ApplicantNidek, Inc.
Decision Date1989-10-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIDEK MODEL ADC-8000 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1989-10-04 under 510(k) number K894709. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK MODEL ADC-8000?

NIDEK MODEL ADC-8000 is a medical device that received FDA 510(k) clearance on 1989-10-04. The listed applicant is Nidek, Inc.. The 510(k) number is K894709.

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

NIDEK MODEL ADC-8000 received FDA 510(k) clearance on 1989-10-04, under 510(k) number K894709.

Who is the listed applicant for NIDEK MODEL ADC-8000?

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 ADC-8000?

The FDA product code for NIDEK MODEL ADC-8000 is GEX. This falls under the Gastroenterology category.

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Other records listing Nidek, Inc. as applicant

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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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