Site-Rite 5 Ultrasound System
FDA 510(k) K052517 · C.R. Bard, Inc.
510(k) numberK052517
Submission
- Device name
- Site-Rite 5 Ultrasound System
- Applicant
- C.R. Bard, Inc.
Salt Lake City, UT, US - Received
- September 14, 2005
- Decision date
- September 29, 2005
- 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 5 Ultrasound System cleared by the FDA?
Site-Rite 5 Ultrasound System (K052517) received a 510(k) decision of Substantially Equivalent on September 29, 2005, 15 days after the submission was received.
What is the product code of K052517?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.