K242681
- 510(k) number
- K242681
- Device name
- NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)
- Applicant
- Nurodata, Inc. TW
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-02-20
- Date received
- 2024-09-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K242681.pdf
Official FDA record: K242681
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.