510(k) K233401
K233401 is an FDA 510(k) premarket notification submitted by Eieling Technology Limited for the device "Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)". The FDA issued a decision of Substantially Equivalent on February 12, 2024. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2024
- Date Received
- October 4, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type