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FDA 510(k)

ULTRASOUND SYSTEM MODEL UF-3500

K-Number: K955543 · 1997-02-11

ApplicantFukuda Denshi USA, Inc.
Decision Date1997-02-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SYSTEM MODEL UF-3500 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 1997-02-11 under 510(k) number K955543. 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 ULTRASOUND SYSTEM MODEL UF-3500?

ULTRASOUND SYSTEM MODEL UF-3500 is a medical device that received FDA 510(k) clearance on 1997-02-11. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K955543.

When did ULTRASOUND SYSTEM MODEL UF-3500 receive FDA 510(k) clearance?

ULTRASOUND SYSTEM MODEL UF-3500 received FDA 510(k) clearance on 1997-02-11, under 510(k) number K955543.

Who is the listed applicant for ULTRASOUND SYSTEM MODEL UF-3500?

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 ULTRASOUND SYSTEM MODEL UF-3500?

The FDA product code for ULTRASOUND SYSTEM MODEL UF-3500 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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