510(k) K100079
K100079 is an FDA 510(k) premarket notification submitted by Shenzhen Well.D Medical Electronics Co., Ltd. for the device "DIGITAL ULTRASOUND SCANNER". The FDA issued a decision of Substantially Equivalent on Mar 1, 2010. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Shenzhen Well.D Medical Electronics Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 1, 2010
- Date Received
- Jan 12, 2010
- 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
- 510(k)