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FDA 510(k)

ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE

K-Number: K844198 · 1984-12-24

ApplicantNidek, Inc.
Decision Date1984-12-24
Product CodeHQB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1984-12-24 under 510(k) number K844198. The device is classified under product code HQB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE?

ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE is a medical device that received FDA 510(k) clearance on 1984-12-24. The listed applicant is Nidek, Inc.. The 510(k) number is K844198.

When did ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE receive FDA 510(k) clearance?

ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE received FDA 510(k) clearance on 1984-12-24, under 510(k) number K844198.

Who is the listed applicant for ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE?

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 ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE?

The FDA product code for ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE is HQB.

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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.

K050336OPD-STATION SOFTWAREK042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300K031733NON-CONTACT TONOMETER, MODEL NT-4000K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000K013694NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)K020876ECHOSCAN, MODEL US-1800

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Related Devices (Code: HQB)

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.

K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical ChandeliersVortex Surgical, Inc.K191846MAXReach Laser ProbeVortex Surgical, Inc.K182646Vitreq disposable laser probes, light fibers and ChandelierVitreQ BVK132614PEREGRINE CURVED ILLUMINATING LASER PROBEPeregrine Surgical , Ltd.K12299723GA CURVED ILLUMINATING LASER PROBEPeregrine Surgical , Ltd.K122905PEREGRINE 23GA CURVED LASER PROBEPeregrine Surgical , Ltd.

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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