Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
FDA 510(k) K150529 · C.R. Bard, Inc.
510(k) numberK150529
Submission
- Device name
- Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
- Applicant
- C.R. Bard, Inc.
Salt Lake Ciy,, UT, US - Received
- March 2, 2015
- Decision date
- March 30, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System cleared by the FDA?
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System (K150529) received a 510(k) decision of Substantially Equivalent on March 30, 2015, 28 days after the submission was received.
What is the product code of K150529?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.