K234153
- 510(k) number
- K234153
- Device name
- EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)
- Applicant
- Edgelife Technologies, LLC FL · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-09-18
- Date received
- 2023-12-29
- 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: K234153.pdf
Official FDA record: K234153
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.