Modification of Acuson V510B Transducer
FDA 510(k) K933663 · Acuson Corp.
510(k) numberK933663
Submission
- Device name
- Modification of Acuson V510B Transducer
- Applicant
- Acuson Corp.
Mountain View, CA, US - Received
- July 28, 1993
- Decision date
- January 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Modification of Acuson V510B Transducer cleared by the FDA?
Modification of Acuson V510B Transducer (K933663) received a 510(k) decision of Substantially Equivalent on January 21, 1994, 177 days after the submission was received.
What is the product code of K933663?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.