FDA 510(k)

MEMO Patch M (MPT-E08R-UNC01)

Número K: K243438 · 2025-12-05

Data da decisão2025-12-05

Código do produtoDXH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

MEMO Patch M (MPT-E08R-UNC01) is the device name listed in this FDA 510(k) record. The listed applicant is Huinno Co., Ltd.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K243438. 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 MEMO Patch M (MPT-E08R-UNC01)?

MEMO Patch M (MPT-E08R-UNC01) is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Huinno Co., Ltd.. The 510(k) number is K243438.

When did MEMO Patch M (MPT-E08R-UNC01) receive FDA 510(k) clearance?

MEMO Patch M (MPT-E08R-UNC01) received FDA 510(k) clearance on 2025-12-05, under 510(k) number K243438.

Who is the listed applicant for MEMO Patch M (MPT-E08R-UNC01)?

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

What is the FDA product code for MEMO Patch M (MPT-E08R-UNC01)?

The FDA product code for MEMO Patch M (MPT-E08R-UNC01) is DXH. This falls under the Hematology category.

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