6VT-D Ultrasound Transducer
FDA 510(k) K141093 · Ge Vingmed Ultrasound AS
510(k) numberK141093
Submission
- Device name
- 6VT-D Ultrasound Transducer
- Applicant
- Ge Vingmed Ultrasound AS
Horten, NO - Received
- April 28, 2014
- Decision date
- May 15, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K101149 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemIYO · Special | 10/13/2010SE |
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Questions and answers
When was 6VT-D Ultrasound Transducer cleared by the FDA?
6VT-D Ultrasound Transducer (K141093) received a 510(k) decision of Substantially Equivalent on May 15, 2014, 17 days after the submission was received.
What is the product code of K141093?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.