Freescan Latex-Free Ultrasound Transducer Cover Kit

FDA 510(k) K050320 · Ascendia Medtech AB

Substantially Equivalent

510(k) numberK050320

Submission

Device name
Freescan Latex-Free Ultrasound Transducer Cover Kit
Applicant
Ascendia Medtech AB
Chester, NY, US
Received
February 9, 2005
Decision date
August 15, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 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 Freescan Latex-Free Ultrasound Transducer Cover Kit cleared by the FDA?

Freescan Latex-Free Ultrasound Transducer Cover Kit (K050320) received a 510(k) decision of Substantially Equivalent on August 15, 2005, 187 days after the submission was received.

What is the product code of K050320?

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