AU530 Diagnostic Ultrasonic Pulsed Echo System

Q: What is the product code of K896356?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.

FDA 510(k) K896356 · Esaote Biomedica Spa

Substantially Equivalent

510(k) numberK896356

Submission

Device name: AU530 Diagnostic Ultrasonic Pulsed Echo System
Applicant: Esaote Biomedica Spa
Cambridge, MA, US
Received: November 6, 1989
Decision date: August 21, 1990
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: IYO – System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1560
Specialty: Radiology

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Questions and answers

When was AU530 Diagnostic Ultrasonic Pulsed Echo System cleared by the FDA?

AU530 Diagnostic Ultrasonic Pulsed Echo System (K896356) received a 510(k) decision of Substantially Equivalent on August 21, 1990, 288 days after the submission was received.

What is the product code of K896356?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.