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FDA 510(k)

NIDEK PRIMA MODEL GYC-1500/2000

K-Number: K980547 · 1998-05-13

ApplicantNidek, Inc.
Decision Date1998-05-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIDEK PRIMA MODEL GYC-1500/2000 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1998-05-13 under 510(k) number K980547. 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 PRIMA MODEL GYC-1500/2000?

NIDEK PRIMA MODEL GYC-1500/2000 is a medical device that received FDA 510(k) clearance on 1998-05-13. The listed applicant is Nidek, Inc.. The 510(k) number is K980547.

When did NIDEK PRIMA MODEL GYC-1500/2000 receive FDA 510(k) clearance?

NIDEK PRIMA MODEL GYC-1500/2000 received FDA 510(k) clearance on 1998-05-13, under 510(k) number K980547.

Who is the listed applicant for NIDEK PRIMA MODEL GYC-1500/2000?

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 PRIMA MODEL GYC-1500/2000?

The FDA product code for NIDEK PRIMA MODEL GYC-1500/2000 is GEX. This falls under the Gastroenterology category.

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Other records listing Nidek, Inc. as applicant

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Related Devices (Code: GEX)

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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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