FDA 510(k)

Wearable Breast Pump (Model S32)

Número K: K240536 · 2024-07-01

RequerenteShenzhen TPH Technology Co., Ltd.

Data da decisão2024-07-01

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wearable Breast Pump (Model S32) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen TPH Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-07-01 under 510(k) number K240536. 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 Wearable Breast Pump (Model S32)?

Wearable Breast Pump (Model S32) is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is Shenzhen TPH Technology Co., Ltd.. The 510(k) number is K240536.

When did Wearable Breast Pump (Model S32) receive FDA 510(k) clearance?

Wearable Breast Pump (Model S32) received FDA 510(k) clearance on 2024-07-01, under 510(k) number K240536.

Who is the listed applicant for Wearable Breast Pump (Model S32)?

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

What is the FDA product code for Wearable Breast Pump (Model S32)?

The FDA product code for Wearable Breast Pump (Model S32) is HGX.

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Outros registros que listam Shenzhen TPH Technology Co., Ltd. como candidato(a)

K254203Wearable Breast Pump (Model S36)K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)K261199Wearable Breast Pump (Model S32A)K260864Mother's Nature W1 Warming Wearable Breast Pump K254244Wearable Breast Pump (Model S39)K260033Wearable Breast Pump (Model S21A)

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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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