UF-760AG

FDA 510(k) K110920 · Fukuda Denshi Co., Ltd.

Substantially Equivalent

510(k) numberK110920

Submission

Device name
UF-760AG
Applicant
Fukuda Denshi Co., Ltd.
Redmond, WA, US
Received
April 1, 2011
Decision date
April 8, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

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Questions and answers

When was UF-760AG cleared by the FDA?

UF-760AG (K110920) received a 510(k) decision of Substantially Equivalent on April 8, 2011, 7 days after the submission was received.

What is the product code of K110920?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.