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FDA 510(k)

Arm automatic blood pressure monitor

K-Number: K161708 · 2016-11-22

ApplicantShenzhen Pump Medical System Co., Ltd.
Decision Date2016-11-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arm automatic blood pressure monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Pump Medical System Co., Ltd.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K161708. 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 Arm automatic blood pressure monitor?

Arm automatic blood pressure monitor is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Shenzhen Pump Medical System Co., Ltd.. The 510(k) number is K161708.

When did Arm automatic blood pressure monitor receive FDA 510(k) clearance?

Arm automatic blood pressure monitor received FDA 510(k) clearance on 2016-11-22, under 510(k) number K161708.

Who is the listed applicant for Arm automatic blood pressure monitor?

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

What is the FDA product code for Arm automatic blood pressure monitor?

The FDA product code for Arm automatic blood pressure monitor is DXN.

Related Clinical Trials

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.

NCT06508619Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation StudyCOMPLETED

Other records listing Shenzhen Pump Medical System 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.

K161712Arm automatic blood pressure monitorK151258Arm automatic blood pressure monitor

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.

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 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.

Official Source

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

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