Site-Rite 6 Ultrasound System, Model Site-Rite 6
FDA 510(k) K071204 · C.R. Bard, Inc.
510(k) numberK071204
Submission
- Device name
- Site-Rite 6 Ultrasound System, Model Site-Rite 6
- Applicant
- C.R. Bard, Inc.
Salt Lake City, UT, US - Received
- May 1, 2007
- Decision date
- May 18, 2007
- 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 6 Ultrasound System, Model Site-Rite 6 cleared by the FDA?
Site-Rite 6 Ultrasound System, Model Site-Rite 6 (K071204) received a 510(k) decision of Substantially Equivalent on May 18, 2007, 17 days after the submission was received.
What is the product code of K071204?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.