510(k) K221568
K221568 is an FDA 510(k) premarket notification submitted by Kolo Medical (Suzhou) Co., Ltd. for the device "KOLO Evolution XHD Series Ultrasound Diagnostic System". The FDA issued a decision of Substantially Equivalent on Sep 12, 2022. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 12, 2022
- Date Received
- May 31, 2022
- 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
- 510(k)