FDA 510(k)

BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)

N.º K: K231969 · 2024-08-30

SolicitanteDongguanshi Yiyingmei Technology Co., Ltd.

Fecha de decisión2024-08-30

Código de productoHGX

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguanshi Yiyingmei Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K231969. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)?

BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Dongguanshi Yiyingmei Technology Co., Ltd.. The 510(k) number is K231969.

When did BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) receive FDA 510(k) clearance?

BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) received FDA 510(k) clearance on 2024-08-30, under 510(k) number K231969.

Who is the listed applicant for BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)?

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

What is the FDA product code for BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)?

The FDA product code for BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) is HGX.

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Dispositivos relacionados (Código: HGX)

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Fuente oficial

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