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FDA 510(k)

Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)

K-Number: K261136 · 2026-07-23

ApplicantGuangzhou Daxin Health Technology Co., Ltd.
Decision Date2026-07-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Daxin Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K261136. 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 Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)?

Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Guangzhou Daxin Health Technology Co., Ltd.. The 510(k) number is K261136.

When did Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) receive FDA 510(k) clearance?

Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) received FDA 510(k) clearance on 2026-07-23, under 510(k) number K261136.

Who is the listed applicant for Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)?

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

What is the FDA product code for Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)?

The FDA product code for Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) is DXN.

Other records listing Guangzhou Daxin Health 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.

K243082Infrared Thermometer

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.

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 GmbHK253059Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)Tournicare Pty, Ltd.K253124Upper arm electronic blood pressure monitor (XB-01)Shenzhen Ziqing Medical Equipment Co., Ltd.K253570Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology Co., Ltd.

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.

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