Fujinon Edu System

FDA 510(k) K894763 · Fujinon, Inc.

Substantially Equivalent

510(k) numberK894763

Submission

Device name
Fujinon Edu System
Applicant
Fujinon, Inc.
Washington, DC, US
Received
July 27, 1989
Decision date
May 22, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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 Fujinon Edu System cleared by the FDA?

Fujinon Edu System (K894763) received a 510(k) decision of Substantially Equivalent on May 22, 1990, 299 days after the submission was received.

What is the product code of K894763?

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