FDA 510(k)

Hexoskin Medical System (7100-00016)

Número K: K243981 · 2025-11-18

Data da decisão2025-11-18

Código do produtoDXH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hexoskin Medical System (7100-00016) is the device name listed in this FDA 510(k) record. The listed applicant is Carre Technologies, Inc.. It received FDA 510(k) clearance on 2025-11-18 under 510(k) number K243981. 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 Hexoskin Medical System (7100-00016)?

Hexoskin Medical System (7100-00016) is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Carre Technologies, Inc.. The 510(k) number is K243981.

When did Hexoskin Medical System (7100-00016) receive FDA 510(k) clearance?

Hexoskin Medical System (7100-00016) received FDA 510(k) clearance on 2025-11-18, under 510(k) number K243981.

Who is the listed applicant for Hexoskin Medical System (7100-00016)?

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

What is the FDA product code for Hexoskin Medical System (7100-00016)?

The FDA product code for Hexoskin Medical System (7100-00016) 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.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.K222842V-Patch Cardiac MonitorShandong Corecare Technology Limited

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.