K241380
- 510(k) number
- K241380
- Device name
- FETOLY-HEART
- Applicant
- Diagnoly FR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-09-11
- Date received
- 2024-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K241380.pdf
Official FDA record: K241380
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.