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FDA 510(k)

MELODY, Remote Control System for Ultrasound Probe

K-Number: K161354 · 2017-06-12

ApplicantAdecho Tech
Decision Date2017-06-12
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MELODY, Remote Control System for Ultrasound Probe is a medical device manufactured by Adecho Tech. It received FDA 510(k) clearance on 2017-06-12 under approval number K161354. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MELODY, Remote Control System for Ultrasound Probe?

MELODY, Remote Control System for Ultrasound Probe is a medical device that received FDA 510(k) clearance on 2017-06-12. It is manufactured by Adecho Tech. The 510(k) number is K161354.

When was MELODY, Remote Control System for Ultrasound Probe approved by the FDA?

MELODY, Remote Control System for Ultrasound Probe received FDA 510(k) clearance on 2017-06-12, under approval number K161354.

What company makes MELODY, Remote Control System for Ultrasound Probe?

MELODY, Remote Control System for Ultrasound Probe is manufactured by Adecho Tech.

What is the FDA product code for MELODY, Remote Control System for Ultrasound Probe?

The FDA product code for MELODY, Remote Control System for Ultrasound Probe is IYO.

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Related PubMed Literature

PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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