Site-Rite Vision II Ultrasound System
FDA 510(k) K132942 · C.R. Bard, Inc.
510(k) numberK132942
Submission
- Device name
- Site-Rite Vision II Ultrasound System
- Applicant
- C.R. Bard, Inc.
Salt Lake Ciy,, UT, US - Received
- September 19, 2013
- Decision date
- October 17, 2013
- 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 Vision II Ultrasound System cleared by the FDA?
Site-Rite Vision II Ultrasound System (K132942) received a 510(k) decision of Substantially Equivalent on October 17, 2013, 28 days after the submission was received.
What is the product code of K132942?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.