510(k) K230986
K230986 is an FDA 510(k) premarket notification submitted by Avantsonic Technology Co., Ltd. for the device "Bladder Scanner". The FDA issued a decision of Substantially Equivalent on Dec 29, 2023. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Avantsonic Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 29, 2023
- Date Received
- Apr 6, 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