C1-6-D Ultrasound Transducer
FDA 510(k) K122921 · GE Healthcare
510(k) numberK122921
Submission
- Device name
- C1-6-D Ultrasound Transducer
- Applicant
- GE Healthcare
Wauwatosa, WI, US - Received
- September 24, 2012
- Decision date
- October 5, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was C1-6-D Ultrasound Transducer cleared by the FDA?
C1-6-D Ultrasound Transducer (K122921) received a 510(k) decision of Substantially Equivalent on October 5, 2012, 11 days after the submission was received.
What is the product code of K122921?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.