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FDA 510(k)

Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

K-Number: K253059 · 2026-06-15

ApplicantTournicare Pty, Ltd.
Decision Date2026-06-15
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) is the device name listed in this FDA 510(k) record. The listed applicant is Tournicare Pty, Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K253059. 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 Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)?

Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Tournicare Pty, Ltd.. The 510(k) number is K253059.

When did Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) receive FDA 510(k) clearance?

Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) received FDA 510(k) clearance on 2026-06-15, under 510(k) number K253059.

Who is the listed applicant for Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)?

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

What is the FDA product code for Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)?

The FDA product code for Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) 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

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 GmbHK253124Upper arm electronic blood pressure monitor (XB-01)Shenzhen Ziqing Medical Equipment Co., Ltd.K253570Blood Pressure Monitor (W06LT)Shenzhen Jamr Technology 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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