FDA 510(k)

Sonosite PX Ultrasound System

Número K: K213763 · 2021-12-27

Data da decisão2021-12-27

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sonosite PX 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 2021-12-27 under 510(k) number K213763. 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 PX Ultrasound System?

Sonosite PX Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-12-27. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K213763.

When did Sonosite PX Ultrasound System receive FDA 510(k) clearance?

Sonosite PX Ultrasound System received FDA 510(k) clearance on 2021-12-27, under 510(k) number K213763.

Who is the listed applicant for Sonosite PX 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 PX Ultrasound System?

The FDA product code for Sonosite PX 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 K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System

Ver todos os 19 dispositivos →

Dispositivos Relacionados (Código: IYN)

Fonte oficial

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