FDA 510(k)

Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)

N.º K: K250185 · 2025-07-14

SolicitanteJiangxi Aicare Medical Technology Co., Ltd.

Fecha de decisión2025-07-14

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Aicare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-14 under 510(k) number K250185. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)?

Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) is a medical device that received FDA 510(k) clearance on 2025-07-14. The listed applicant is Jiangxi Aicare Medical Technology Co., Ltd.. The 510(k) number is K250185.

When did Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) receive FDA 510(k) clearance?

Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) received FDA 510(k) clearance on 2025-07-14, under 510(k) number K250185.

Who is the listed applicant for Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)?

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

What is the FDA product code for Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)?

The FDA product code for Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) is DXN.

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Otros registros que enlistan a Jiangxi Aicare Medical Technology Co., Ltd. como solicitante

K221040Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)

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Fuente oficial

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