510(k) K173265
K173265 is an FDA 510(k) premarket notification submitted by Winprobe Corporation for the device "UltraVision 2 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on Nov 7, 2017. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Winprobe Corporation has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 7, 2017
- Date Received
- Oct 11, 2017
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type
- 510(k)