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FDA 510(k)

NIDEK INC. MODEL AC-2000 DERM

K-Number: K904402 · 1990-12-07

ApplicantNidek, Inc.
Decision Date1990-12-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIDEK INC. MODEL AC-2000 DERM is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1990-12-07 under 510(k) number K904402. 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 INC. MODEL AC-2000 DERM?

NIDEK INC. MODEL AC-2000 DERM is a medical device that received FDA 510(k) clearance on 1990-12-07. The listed applicant is Nidek, Inc.. The 510(k) number is K904402.

When did NIDEK INC. MODEL AC-2000 DERM receive FDA 510(k) clearance?

NIDEK INC. MODEL AC-2000 DERM received FDA 510(k) clearance on 1990-12-07, under 510(k) number K904402.

Who is the listed applicant for NIDEK INC. MODEL AC-2000 DERM?

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 INC. MODEL AC-2000 DERM?

The FDA product code for NIDEK INC. MODEL AC-2000 DERM is GEX. This falls under the Gastroenterology category.

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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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