510(k) K234153
EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) by
Edgelife Technologies, LLC
— Product Code IYN
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2024
- Date Received
- December 29, 2023
- 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