FDA 510(k)

Transcranial Doppler Ultrasound System

Número K: K173801 · 2018-07-11

RequerenteShenzhen Delica Medical Equipment Co., Ltd.

Data da decisão2018-07-11

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Transcranial Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Delica Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2018-07-11 under 510(k) number K173801. 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 Transcranial Doppler Ultrasound System?

Transcranial Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Shenzhen Delica Medical Equipment Co., Ltd.. The 510(k) number is K173801.

When did Transcranial Doppler Ultrasound System receive FDA 510(k) clearance?

Transcranial Doppler Ultrasound System received FDA 510(k) clearance on 2018-07-11, under 510(k) number K173801.

Who is the listed applicant for Transcranial Doppler Ultrasound System?

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

What is the FDA product code for Transcranial Doppler Ultrasound System?

The FDA product code for Transcranial Doppler Ultrasound System is IYN.

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Outros registros que listam Shenzhen Delica Medical Equipment Co., Ltd. como candidato(a)

K213009Transcranial Doppler Ultrasound System K190228Transcranial Doppler Ultrasound System

Dispositivos Relacionados (Código: IYN)

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