510(k) K250228
K250228 is an FDA 510(k) premarket notification submitted by Esonic Technology (Wuhan) Co., Ltd. for the device "eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)". The FDA issued a decision of Substantially Equivalent on April 23, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2025
- Date Received
- January 27, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type