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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 the device name listed in this FDA 510(k) record. The listed applicant is Adecho Tech. It received FDA 510(k) clearance on 2017-06-12 under 510(k) 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. The listed applicant is Adecho Tech. The 510(k) number is K161354.

When did MELODY, Remote Control System for Ultrasound Probe receive FDA 510(k) clearance?

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

Who is the listed applicant for MELODY, Remote Control System for Ultrasound Probe?

The FDA 510(k) record lists Adecho Tech as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: IYO)

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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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