FDA 510(k)

RXiBreeze PAP System (RXiBreeze 20C)

Número K: K253044 · 2026-07-23

RequerenteResvent Medical Technology Co., Ltd.

Data da decisão2026-07-23

Código do produtoBZD

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

RXiBreeze PAP System (RXiBreeze 20C) is the device name listed in this FDA 510(k) record. The listed applicant is Resvent Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K253044. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RXiBreeze PAP System (RXiBreeze 20C)?

RXiBreeze PAP System (RXiBreeze 20C) is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Resvent Medical Technology Co., Ltd.. The 510(k) number is K253044.

When did RXiBreeze PAP System (RXiBreeze 20C) receive FDA 510(k) clearance?

RXiBreeze PAP System (RXiBreeze 20C) received FDA 510(k) clearance on 2026-07-23, under 510(k) number K253044.

Who is the listed applicant for RXiBreeze PAP System (RXiBreeze 20C)?

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

What is the FDA product code for RXiBreeze PAP System (RXiBreeze 20C)?

The FDA product code for RXiBreeze PAP System (RXiBreeze 20C) is BZD.

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

Dispositivos Relacionados (Código: BZD)

K261262Altis Full Face MaskRespironics, Inc.K253553OrionResmed Corp K254104ResScan EssentialsResmed Corp K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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.