K233841
- 510(k) number
- K233841
- Device name
- HD80 Series Ultrasound Diagnostic System
- Applicant
- Qingdao Hisense Medical Equipment Co., Ltd. CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-05-16
- Date received
- 2023-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233841.pdf
Official FDA record: K233841
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.