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FDA 510(k)

NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA

K-Number: K900890 · 1990-09-10

ApplicantNidek, Inc.
Decision Date1990-09-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1990-09-10 under 510(k) number K900890. 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 MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA?

NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA is a medical device that received FDA 510(k) clearance on 1990-09-10. The listed applicant is Nidek, Inc.. The 510(k) number is K900890.

When did NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA receive FDA 510(k) clearance?

NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA received FDA 510(k) clearance on 1990-09-10, under 510(k) number K900890.

Who is the listed applicant for NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA?

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 AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA?

The FDA product code for NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA 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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