FDA 510(k)

Hexoskin Medical System (7100-00016)

Номер K: K243981 · 2025-11-18

Дата решения2025-11-18

Код продуктаDXH

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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

Официальный источник

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