Acuson V510 Transducer
FDA 510(k) K911767 · Acuson Corp.
510(k) numberK911767
Submission
- Device name
- Acuson V510 Transducer
- Applicant
- Acuson Corp.
Mountain View, CA, US - Received
- April 19, 1991
- Decision date
- October 31, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Acuson V510 Transducer cleared by the FDA?
Acuson V510 Transducer (K911767) received a 510(k) decision of Substantially Equivalent on October 31, 1991, 195 days after the submission was received.
What is the product code of K911767?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.