510(k) K232787
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2023
- Date Received
- September 11, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasound Guided Nerve Block Assist
- Device Class
- Class II
- Regulation Number
- 868.1980
- Review Panel
- AN
- Submission Type
This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.