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FDA 510(k)

FUKUDA DENSHI MODEL HJ-310

K-Number: K901889 · 1990-07-17

ApplicantFukuda Denshi USA, Inc.
Decision Date1990-07-17
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI MODEL HJ-310 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 1990-07-17 under 510(k) number K901889. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA DENSHI MODEL HJ-310?

FUKUDA DENSHI MODEL HJ-310 is a medical device that received FDA 510(k) clearance on 1990-07-17. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K901889.

When did FUKUDA DENSHI MODEL HJ-310 receive FDA 510(k) clearance?

FUKUDA DENSHI MODEL HJ-310 received FDA 510(k) clearance on 1990-07-17, under 510(k) number K901889.

Who is the listed applicant for FUKUDA DENSHI MODEL HJ-310?

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 HJ-310?

The FDA product code for FUKUDA DENSHI MODEL HJ-310 is DXN.

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Related Devices (Code: DXN)

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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