Phased Array Transducer - - PVF -375DT
FDA 510(k) K972771 · Toshiba America Medical Systems, In.C
510(k) numberK972771
Submission
- Device name
- Phased Array Transducer - - PVF -375DT
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- July 24, 1997
- Decision date
- February 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Phased Array Transducer - - PVF -375DT cleared by the FDA?
Phased Array Transducer - - PVF -375DT (K972771) received a 510(k) decision of Substantially Equivalent on February 11, 1998, 202 days after the submission was received.
What is the product code of K972771?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.