FDA 510(k)

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

Numéro K : K221040 · 2022-08-31

DemandeurJiangxi Aicare Medical Technology Co., Ltd.

Date de décision2022-08-31

Code produitDXN

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) 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 2022-08-31 under 510(k) number K221040. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)?

Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) is a medical device that received FDA 510(k) clearance on 2022-08-31. The listed applicant is Jiangxi Aicare Medical Technology Co., Ltd.. The 510(k) number is K221040.

When did Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) receive FDA 510(k) clearance?

Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) received FDA 510(k) clearance on 2022-08-31, under 510(k) number K221040.

Who is the listed applicant for Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)?

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, Model: X1, X2, X5, X6, X7,X8, X11)?

The FDA product code for Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) is DXN.

Essais cliniques associés

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Autres dossiers indiquant Jiangxi Aicare Medical Technology Co., Ltd. en tant que demandeur

K250185Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)

Dispositifs connexes (Code : DXN)

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Source officielle

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