FDA 510(k)

Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)

Numéro K : K251795 · 2025-10-09

Date de décision2025-10-09

Code produitDXN

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) is the device name listed in this FDA 510(k) record. The listed applicant is Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2025-10-09 under 510(k) number K251795. 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 Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)?

Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Honsun (Nantong) Co., Ltd.. The 510(k) number is K251795.

When did Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) receive FDA 510(k) clearance?

Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) received FDA 510(k) clearance on 2025-10-09, under 510(k) number K251795.

Who is the listed applicant for Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)?

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

What is the FDA product code for Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)?

The FDA product code for Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) is DXN.

Essais cliniques associés

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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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