Sheathesiso Ultrasound Transducer Cover
FDA 510(k) K091828 · Sheathing Technologies, Inc.
510(k) numberK091828
Submission
- Device name
- Sheathesiso Ultrasound Transducer Cover
- Applicant
- Sheathing Technologies, Inc.
Morgan Hill, CA, US - Received
- June 19, 2009
- Decision date
- September 28, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sheathesiso Ultrasound Transducer Cover cleared by the FDA?
Sheathesiso Ultrasound Transducer Cover (K091828) received a 510(k) decision of Substantially Equivalent on September 28, 2009, 101 days after the submission was received.
What is the product code of K091828?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.