510(k) K223902
K223902 is an FDA 510(k) premarket notification submitted by Echosens for the device "FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)". The FDA issued a decision of Substantially Equivalent on Mar 2, 2023. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Echosens has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 2, 2023
- Date Received
- Dec 28, 2022
- 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
- 510(k)