K241662
- 510(k) number
- K241662
- Device name
- Ultrasound Transducer Cover
- Applicant
- Vitrolife Sweden AB SE
- Product code
- ITX — Transducer, Ultrasonic, Diagnostic
- Decision date
- 2024-08-30
- Date received
- 2024-06-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241662.pdf
Official FDA record: K241662
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.