FDA 510(k)

Philips Avent Comfort Single/Twin Electric Breast Pump

Número K: K161532 · 2016-08-29

RequerentePhilips Consumer Lifestyle - Innovation Site Eindhoven

Data da decisão2016-08-29

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Philips Avent Comfort Single/Twin Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Philips Consumer Lifestyle - Innovation Site Eindhoven. It received FDA 510(k) clearance on 2016-08-29 under 510(k) number K161532. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Philips Avent Comfort Single/Twin Electric Breast Pump?

Philips Avent Comfort Single/Twin Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is Philips Consumer Lifestyle - Innovation Site Eindhoven. The 510(k) number is K161532.

When did Philips Avent Comfort Single/Twin Electric Breast Pump receive FDA 510(k) clearance?

Philips Avent Comfort Single/Twin Electric Breast Pump received FDA 510(k) clearance on 2016-08-29, under 510(k) number K161532.

Who is the listed applicant for Philips Avent Comfort Single/Twin Electric Breast Pump?

The FDA 510(k) record lists Philips Consumer Lifestyle - Innovation Site Eindhoven as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips Avent Comfort Single/Twin Electric Breast Pump?

The FDA product code for Philips Avent Comfort Single/Twin Electric Breast Pump is HGX.

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Outros registros que listam Philips Consumer Lifestyle - Innovation Site Eindhoven como candidato(a)

K203383Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 K201381Philips Avent Single/Double electric breast pump Advanced

Dispositivos Relacionados (Código: HGX)

K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.

Fonte oficial

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