510(k) K183041
K183041 is an FDA 510(k) premarket notification submitted by Wuhan Zoncare Bio-Medical Electronics Co., Ltd. for the device "Full Digital Colour Doppler Ultrasonic Diagnostic System". The FDA issued a decision of Substantially Equivalent on Jul 10, 2019. 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
- Jul 10, 2019
- Date Received
- Nov 1, 2018
- 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)