FDA 510(k)

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

Numéro K : K250185 · 2025-07-14

DemandeurJiangxi Aicare Medical Technology Co., Ltd.

Date de décision2025-07-14

Code produitDXN

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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

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

Dispositifs connexes (Code : DXN)

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Source officielle

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