510(k) K190120
K190120 is an FDA 510(k) premarket notification submitted by Vinno Technology (Suzhou) Co.,Ltd for the device "VINNO 8, VINNO 6, VINNO 5". The FDA issued a decision of Substantially Equivalent on January 23, 2020. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Vinno Technology (Suzhou) Co.,Ltd has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2020
- Date Received
- January 24, 2019
- 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