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FDA 510(k)

FUKUDA DENSHI EH-11

K-Number: K834059 · 1985-06-21

ApplicantFukuda Denshi USA, Inc.
Decision Date1985-06-21
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI EH-11 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 1985-06-21 under 510(k) number K834059. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUKUDA DENSHI EH-11?

FUKUDA DENSHI EH-11 is a medical device that received FDA 510(k) clearance on 1985-06-21. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K834059.

When did FUKUDA DENSHI EH-11 receive FDA 510(k) clearance?

FUKUDA DENSHI EH-11 received FDA 510(k) clearance on 1985-06-21, under 510(k) number K834059.

Who is the listed applicant for FUKUDA DENSHI EH-11?

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 EH-11?

The FDA product code for FUKUDA DENSHI EH-11 is DXG.

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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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