FDA 510(k)

ECG SENTINEL System

Número K: K172801 · 2017-10-18

Data da decisão2017-10-18

Código do produtoDXH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ECG SENTINEL System is the device name listed in this FDA 510(k) record. The listed applicant is Cardiomedix, Inc.. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K172801. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ECG SENTINEL System?

ECG SENTINEL System is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Cardiomedix, Inc.. The 510(k) number is K172801.

When did ECG SENTINEL System receive FDA 510(k) clearance?

ECG SENTINEL System received FDA 510(k) clearance on 2017-10-18, under 510(k) number K172801.

Who is the listed applicant for ECG SENTINEL System?

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

What is the FDA product code for ECG SENTINEL System?

The FDA product code for ECG SENTINEL System is DXH. This falls under the Hematology category.

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: DXH)

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, 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.