FDA 510(k)

CMS600P2 B-Ultrasound Diagnostic System

Número K: K170856 · 2017-11-17

RequerenteContec Medical Systems Co.,Ltd

Data da decisão2017-11-17

Código do produtoIYO

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

CMS600P2 B-Ultrasound Diagnostic System is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K170856. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CMS600P2 B-Ultrasound Diagnostic System?

CMS600P2 B-Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Contec Medical Systems Co.,Ltd. The 510(k) number is K170856.

When did CMS600P2 B-Ultrasound Diagnostic System receive FDA 510(k) clearance?

CMS600P2 B-Ultrasound Diagnostic System received FDA 510(k) clearance on 2017-11-17, under 510(k) number K170856.

Who is the listed applicant for CMS600P2 B-Ultrasound Diagnostic System?

The FDA 510(k) record lists Contec Medical Systems Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMS600P2 B-Ultrasound Diagnostic System?

The FDA product code for CMS600P2 B-Ultrasound Diagnostic System is IYO.

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Outros registros que listam Contec Medical Systems Co.,Ltd como candidato(a)

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Fonte oficial

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