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FDA 510(k)

NIDEK MODEL AKC-8000

K-Number: K894273 · 1989-08-07

ApplicantNidek, Inc.
Decision Date1989-08-07
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK MODEL AKC-8000 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1989-08-07 under 510(k) number K894273. 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 AKC-8000?

NIDEK MODEL AKC-8000 is a medical device that received FDA 510(k) clearance on 1989-08-07. The listed applicant is Nidek, Inc.. The 510(k) number is K894273.

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

NIDEK MODEL AKC-8000 received FDA 510(k) clearance on 1989-08-07, under 510(k) number K894273.

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

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?

The FDA product code for NIDEK MODEL AKC-8000 is HQF.

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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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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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