FDA 510(k)

Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)

Numéro K : K241590 · 2025-02-03

DemandeurGuangdong Xinyu Electronic and Technology Co., Ltd.

Date de décision2025-02-03

Code produitDXN

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Xinyu Electronic and Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-03 under 510(k) number K241590. 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 Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)?

Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) is a medical device that received FDA 510(k) clearance on 2025-02-03. The listed applicant is Guangdong Xinyu Electronic and Technology Co., Ltd.. The 510(k) number is K241590.

When did Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) receive FDA 510(k) clearance?

Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) received FDA 510(k) clearance on 2025-02-03, under 510(k) number K241590.

Who is the listed applicant for Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)?

The FDA 510(k) record lists Guangdong Xinyu Electronic and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)?

The FDA product code for Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) is DXN.

Essais cliniques associés

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Autres dossiers indiquant Guangdong Xinyu Electronic and Technology Co., Ltd. en tant que demandeur

K241634Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)

Dispositifs connexes (Code : DXN)

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

Source officielle

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