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FDA 510(k)

NIDEK MODELS AC-2100 & 2200

K-Number: K913465 · 1991-10-21

ApplicantNidek, Inc.
Decision Date1991-10-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIDEK MODELS AC-2100 & 2200 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1991-10-21 under 510(k) number K913465. 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 MODELS AC-2100 & 2200?

NIDEK MODELS AC-2100 & 2200 is a medical device that received FDA 510(k) clearance on 1991-10-21. The listed applicant is Nidek, Inc.. The 510(k) number is K913465.

When did NIDEK MODELS AC-2100 & 2200 receive FDA 510(k) clearance?

NIDEK MODELS AC-2100 & 2200 received FDA 510(k) clearance on 1991-10-21, under 510(k) number K913465.

Who is the listed applicant for NIDEK MODELS AC-2100 & 2200?

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 MODELS AC-2100 & 2200?

The FDA product code for NIDEK MODELS AC-2100 & 2200 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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