UF-870 AG Diagnostic Ultrasound System

FDA 510(k) K081919 · Fukuda Denshi Co., Ltd.

Substantially Equivalent

510(k) numberK081919

Submission

Device name
UF-870 AG Diagnostic Ultrasound System
Applicant
Fukuda Denshi Co., Ltd.
Redmond, WA, US
Received
July 7, 2008
Decision date
September 9, 2008
Decision
Substantially Equivalent (SESE)
Type
Special 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-870 AG Diagnostic Ultrasound System cleared by the FDA?

UF-870 AG Diagnostic Ultrasound System (K081919) received a 510(k) decision of Substantially Equivalent on September 9, 2008, 64 days after the submission was received.

What is the product code of K081919?

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