K240516
- 510(k) number
- K240516
- Device name
- RS85 Diagnostic Ultrasound System
- Applicant
- Samsung Medison Co., Ltd. KR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-06-12
- Date received
- 2024-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K240516.pdf
Official FDA record: K240516
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.