510(k) K161354
K161354 is an FDA 510(k) premarket notification submitted by Adecho Tech for the device "MELODY, Remote Control System for Ultrasound Probe". The FDA issued a decision of Substantially Equivalent on Jun 12, 2017. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 12, 2017
- Date Received
- May 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type
- 510(k)