Site Rite Prevue Ultrasound System and Pinpoint Needle Guide
FDA 510(k) K120882 · Bard Access Systems, Inc.
510(k) numberK120882
Submission
- Device name
- Site Rite Prevue Ultrasound System and Pinpoint Needle Guide
- Applicant
- Bard Access Systems, Inc.
Salt Lake Ciy,, UT, US - Received
- March 23, 2012
- Decision date
- May 30, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Site Rite Prevue Ultrasound System and Pinpoint Needle Guide cleared by the FDA?
Site Rite Prevue Ultrasound System and Pinpoint Needle Guide (K120882) received a 510(k) decision of Substantially Equivalent on May 30, 2012, 68 days after the submission was received.
What is the product code of K120882?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.