K242167
- 510(k) number
- K242167
- Device name
- Sterile and Non-Sterile Ultrasonic Coupling Agent
- Applicant
- Anhui Deepblue Medical Technology Co., Ltd. CN
- Product code
- MUI — Media, Coupling, Ultrasound
- Decision date
- 2024-09-19
- Date received
- 2024-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K242167.pdf
Official FDA record: K242167
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.