510(k) K190039
K190039 is an FDA 510(k) premarket notification submitted by Sonavex, Inc. for the device "EchoSure Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on March 8, 2019. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Sonavex, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2019
- Date Received
- January 8, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type