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FDA 510(k)

NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR

K-Number: K903639 · 1991-02-04

ApplicantNidek, Inc.
Decision Date1991-02-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1991-02-04 under 510(k) number K903639. 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 DC-3000 DIODE LASER PHOTOCOAGULATOR?

NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1991-02-04. The listed applicant is Nidek, Inc.. The 510(k) number is K903639.

When did NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR receive FDA 510(k) clearance?

NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR received FDA 510(k) clearance on 1991-02-04, under 510(k) number K903639.

Who is the listed applicant for NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR?

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 DC-3000 DIODE LASER PHOTOCOAGULATOR?

The FDA product code for NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR is GEX. This falls under the Gastroenterology category.

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Other records listing Nidek, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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