K232957
- 510(k) number
- K232957
- Device name
- Sterile and Non-Sterile Ultrasound Gels
- Applicant
- Jianerkang Medical Co., Ltd. CN
- Product code
- MUI — Media, Coupling, Ultrasound
- Decision date
- 2023-12-15
- Date received
- 2023-09-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232957.pdf
Official FDA record: K232957
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.