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FDA 510(k)

FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500

K-Number: K981404 · 1998-05-20

ApplicantFukuda Denshi USA, Inc.
Decision Date1998-05-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 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 1998-05-20 under 510(k) number K981404. 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 FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500?

FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K981404.

When did FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 receive FDA 510(k) clearance?

FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 received FDA 510(k) clearance on 1998-05-20, under 510(k) number K981404.

Who is the listed applicant for FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500?

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 ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500?

The FDA product code for FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 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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