FDA 510(k)

SonoSite SII Ultrasound System

Número K: K160734 · 2016-04-05

Data da decisão2016-04-05

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

SonoSite SII Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K160734. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SonoSite SII Ultrasound System?

SonoSite SII Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K160734.

When did SonoSite SII Ultrasound System receive FDA 510(k) clearance?

SonoSite SII Ultrasound System received FDA 510(k) clearance on 2016-04-05, under 510(k) number K160734.

Who is the listed applicant for SonoSite SII Ultrasound System?

The FDA 510(k) record lists FUJIFILM Sonosite, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SonoSite SII Ultrasound System?

The FDA product code for SonoSite SII Ultrasound System is IYN.

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Outros registros que listam FUJIFILM Sonosite, Inc. como candidato(a)

K260595Sonosite iLOOK Ultrasound System K253448Sonosite MT Ultrasound System K251106Sonosite LX and Sonosite PX Ultrasound Systems K251830Sonosite LX Ultrasound System K233597Sonosite LX Ultrasound System K213763Sonosite PX Ultrasound System

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Dispositivos Relacionados (Código: IYN)

Fonte oficial

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