FDA 510(k)

Sistema de Imagiologia de Doppler Color Digital Apogee 5500/Apogee 5300/Apogee 5800

Número K: K160853 · 2016-06-27

RequerenteShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

Data da decisão2016-06-27

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). It received FDA 510(k) clearance on 2016-06-27 under 510(k) number K160853. 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 Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System?

Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2016-06-27. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K160853.

When did Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System receive FDA 510(k) clearance?

Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System received FDA 510(k) clearance on 2016-06-27, under 510(k) number K160853.

Who is the listed applicant for Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System?

The FDA 510(k) record lists Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System?

The FDA product code for Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System is IYN.

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Outros registros que listam Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) como candidato(a)

K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System K210318Sistema de Imagiologia de Doppler Color Digital Apogee 6500,Apogee 6300,Apogee 6200 K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System K200637SR-8100 Portable X-ray Unit K200976SR-8230, SR-8230S Portable X-ray Unit

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: IYN)

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