K231283
- 510(k) number
- K231283
- Device name
- SiteRite 9 Ultrasound System
- Applicant
- Bard Access Systems, Inc. (C.R. Bard, Inc.) UT · US
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2023-09-11
- Date received
- 2023-05-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 10.4 MB · U.S. public domain
Also available from FDA: K231283.pdf
Official FDA record: K231283
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.