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FDA 510(k)

NIDEK CYBERSCAN

K-Number: K970017 · 1997-03-18

ApplicantNidek, Inc.
Decision Date1997-03-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIDEK CYBERSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1997-03-18 under 510(k) number K970017. 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 CYBERSCAN?

NIDEK CYBERSCAN is a medical device that received FDA 510(k) clearance on 1997-03-18. The listed applicant is Nidek, Inc.. The 510(k) number is K970017.

When did NIDEK CYBERSCAN receive FDA 510(k) clearance?

NIDEK CYBERSCAN received FDA 510(k) clearance on 1997-03-18, under 510(k) number K970017.

Who is the listed applicant for NIDEK CYBERSCAN?

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 CYBERSCAN?

The FDA product code for NIDEK CYBERSCAN 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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