K230179
- 510(k) number
- K230179
- Device name
- 6440 MyLabX90
- Applicant
- Esaote, S.p.A. IT
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2023-11-29
- Date received
- 2023-01-23
- 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: K230179.pdf
Official FDA record: K230179
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.