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FDA 510(k)

MELODY，超聲探頭遙控系統

K 號：K161354 · 2017-06-12

申請人Adecho Tech
決定日期2017-06-12
產品代碼IYO
諮詢委員會RA
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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官方來源

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