510(k) K211746
K211746 is an FDA 510(k) premarket notification submitted by Guangdong Youkey Medical Co., Ltd. for the device "Pocket Ultrasound System". The FDA issued a decision of Substantially Equivalent on February 18, 2022. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Guangdong Youkey Medical Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2022
- Date Received
- June 7, 2021
- 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