FDA 510(k)

MELODY, Remote Control System for Ultrasound Probe

Номер K: K161354 · 2017-06-12

ЗаявительAdecho Tech

Дата решения2017-06-12

Код продуктаIYO

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: IYO)

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

Официальный источник

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