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FDA 510(k)

FUKUDA DENSHI MODEL HG-301

K-Number: K921454 · 1994-04-01

ApplicantFukuda Denshi USA, Inc.
Decision Date1994-04-01
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI MODEL HG-301 is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 1994-04-01 under 510(k) number K921454. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA DENSHI MODEL HG-301?

FUKUDA DENSHI MODEL HG-301 is a medical device that received FDA 510(k) clearance on 1994-04-01. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K921454.

When did FUKUDA DENSHI MODEL HG-301 receive FDA 510(k) clearance?

FUKUDA DENSHI MODEL HG-301 received FDA 510(k) clearance on 1994-04-01, under 510(k) number K921454.

Who is the listed applicant for FUKUDA DENSHI MODEL HG-301?

The FDA 510(k) record lists Fukuda Denshi USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUKUDA DENSHI MODEL HG-301?

The FDA product code for FUKUDA DENSHI MODEL HG-301 is DQA.

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Other records listing Fukuda Denshi USA, Inc. as applicant

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Related Devices (Code: DQA)

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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