FDA 510(k)

Smart double sides wearable breast pump, Electric bilateral breast pump

Numéro K : K230102 · 2023-09-21

DemandeurHuizhou Lvb Maternal and Infant Supplies Co., Ltd.

Date de décision2023-09-21

Code produitHGX

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Smart double sides wearable breast pump, Electric bilateral breast pump is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. It received FDA 510(k) clearance on 2023-09-21 under 510(k) number K230102. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Smart double sides wearable breast pump, Electric bilateral breast pump?

Smart double sides wearable breast pump, Electric bilateral breast pump is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. The 510(k) number is K230102.

When did Smart double sides wearable breast pump, Electric bilateral breast pump receive FDA 510(k) clearance?

Smart double sides wearable breast pump, Electric bilateral breast pump received FDA 510(k) clearance on 2023-09-21, under 510(k) number K230102.

Who is the listed applicant for Smart double sides wearable breast pump, Electric bilateral breast pump?

The FDA 510(k) record lists Huizhou Lvb Maternal and Infant Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart double sides wearable breast pump, Electric bilateral breast pump?

The FDA product code for Smart double sides wearable breast pump, Electric bilateral breast pump is HGX.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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

Autres dossiers indiquant Huizhou Lvb Maternal and Infant Supplies Co., Ltd. en tant que demandeur

K252192Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)K241004Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)

Dispositifs connexes (Code : 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.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.