Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Digital Blood Pressure Monitor WBP Series

K-Number: K231542 · 2023-09-07

ApplicantWeony (Shenzhen) Technology Co., Ltd.
Decision Date2023-09-07
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Blood Pressure Monitor WBP Series is the device name listed in this FDA 510(k) record. The listed applicant is Weony (Shenzhen) Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K231542. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Blood Pressure Monitor WBP Series?

Digital Blood Pressure Monitor WBP Series is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Weony (Shenzhen) Technology Co., Ltd.. The 510(k) number is K231542.

When did Digital Blood Pressure Monitor WBP Series receive FDA 510(k) clearance?

Digital Blood Pressure Monitor WBP Series received FDA 510(k) clearance on 2023-09-07, under 510(k) number K231542.

Who is the listed applicant for Digital Blood Pressure Monitor WBP Series?

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

What is the FDA product code for Digital Blood Pressure Monitor WBP Series?

The FDA product code for Digital Blood Pressure Monitor WBP Series is DXN.

Other records listing Weony (Shenzhen) Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210671Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261061BP Go (BPP-855)Wellvii, Inc.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.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑