Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Bombona de Seno Annabella Doble (ADO-US23-1000)

N.º K: K241506 · 2024-06-27

SolicitanteAnnabella Tech
Fecha de decisión2024-06-27
Código de productoHGX
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del dispositivo

Annabella Double Breast Pump (ADO-US23-1000) is the device name listed in this FDA 510(k) record. The listed applicant is Annabella Tech. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K241506. 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 Annabella Double Breast Pump (ADO-US23-1000)?

Annabella Double Breast Pump (ADO-US23-1000) is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Annabella Tech. The 510(k) number is K241506.

When did Annabella Double Breast Pump (ADO-US23-1000) receive FDA 510(k) clearance?

Annabella Double Breast Pump (ADO-US23-1000) received FDA 510(k) clearance on 2024-06-27, under 510(k) number K241506.

Who is the listed applicant for Annabella Double Breast Pump (ADO-US23-1000)?

The FDA 510(k) record lists Annabella Tech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Annabella Double Breast Pump (ADO-US23-1000)?

The FDA product code for Annabella Double Breast Pump (ADO-US23-1000) is HGX.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: HGX)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑