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FDA 510(k)

EUB-405

K-Number: K924126 · 1992-12-10

ApplicantHitachi Medical Systems America, Inc.
Decision Date1992-12-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EUB-405 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 1992-12-10 under 510(k) number K924126. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUB-405?

EUB-405 is a medical device that received FDA 510(k) clearance on 1992-12-10. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K924126.

When did EUB-405 receive FDA 510(k) clearance?

EUB-405 received FDA 510(k) clearance on 1992-12-10, under 510(k) number K924126.

Who is the listed applicant for EUB-405?

The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUB-405?

The FDA product code for EUB-405 is IYO.

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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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