AT3C70 Transducer

FDA 510(k) K002856 · Sonora Medical Systems

Substantially Equivalent

510(k) numberK002856

Submission

Device name
AT3C70 Transducer
Applicant
Sonora Medical Systems
Indianpolis, IN, US
Received
September 13, 2000
Decision date
April 2, 2001
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

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 AT3C70 Transducer cleared by the FDA?

AT3C70 Transducer (K002856) received a 510(k) decision of Substantially Equivalent on April 2, 2001, 201 days after the submission was received.

What is the product code of K002856?

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