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FDA 510(k)

NIDEK MODEL GYC-1500 AND GYC-2000

K-Number: K951079 · 1995-09-14

ApplicantNidek, Inc.
Decision Date1995-09-14
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK MODEL GYC-1500 AND GYC-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 1995-09-14 under 510(k) number K951079. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK MODEL GYC-1500 AND GYC-2000?

NIDEK MODEL GYC-1500 AND GYC-2000 is a medical device that received FDA 510(k) clearance on 1995-09-14. The listed applicant is Nidek, Inc.. The 510(k) number is K951079.

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

NIDEK MODEL GYC-1500 AND GYC-2000 received FDA 510(k) clearance on 1995-09-14, under 510(k) number K951079.

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

The FDA product code for NIDEK MODEL GYC-1500 AND GYC-2000 is HQF.

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Other records listing Nidek, Inc. as applicant

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Related Devices (Code: HQF)

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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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