FDA 510(k)

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

Número K: K231969 · 2024-08-30

RequerenteDongguanshi Yiyingmei Technology Co., Ltd.

Data da decisão2024-08-30

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Dongguanshi Yiyingmei Technology Co., Ltd. como candidato(a)

K242028Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)

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

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.