MELODY, Remote Control System for Ultrasound Probe
FDA 510(k) K161354 · Adecho Tech
510(k) numberK161354
Submission
- Device name
- MELODY, Remote Control System for Ultrasound Probe
- Applicant
- Adecho Tech
Naveil, FR - Received
- May 16, 2016
- Decision date
- June 12, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MELODY, Remote Control System for Ultrasound Probe cleared by the FDA?
MELODY, Remote Control System for Ultrasound Probe (K161354) received a 510(k) decision of Substantially Equivalent on June 12, 2017, 392 days after the submission was received.
What is the product code of K161354?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.