Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Integrated CardioRespiratory System

Número K: K173156 · 2018-06-08

RequerenteSensydia, Inc.
Data da decisão2018-06-08
Código do produtoMWJ
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Integrated CardioRespiratory System is the device name listed in this FDA 510(k) record. The listed applicant is Sensydia, Inc.. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K173156. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Integrated CardioRespiratory System?

Integrated CardioRespiratory System is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is Sensydia, Inc.. The 510(k) number is K173156.

When did Integrated CardioRespiratory System receive FDA 510(k) clearance?

Integrated CardioRespiratory System received FDA 510(k) clearance on 2018-06-08, under 510(k) number K173156.

Who is the listed applicant for Integrated CardioRespiratory System?

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

What is the FDA product code for Integrated CardioRespiratory System?

The FDA product code for Integrated CardioRespiratory System is MWJ.

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_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: MWJ)

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.

K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)Shenzhen Xinyan Medical Technology Co.,ltd.K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.K253562medilogFDSchiller AGK253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, 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.

↑