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FDA 510(k)

Wrist Type Blood Pressure Monitor

K-Number: K220651 · 2022-06-30

ApplicantShenzhen Jamr Medical Technology Co., Ltd.
Decision Date2022-06-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist Type Blood Pressure Monitor is a medical device manufactured by Shenzhen Jamr Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-30 under approval number K220651. 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 Wrist Type Blood Pressure Monitor?

Wrist Type Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2022-06-30. It is manufactured by Shenzhen Jamr Medical Technology Co., Ltd.. The 510(k) number is K220651.

When was Wrist Type Blood Pressure Monitor approved by the FDA?

Wrist Type Blood Pressure Monitor received FDA 510(k) clearance on 2022-06-30, under approval number K220651.

What company makes Wrist Type Blood Pressure Monitor?

Wrist Type Blood Pressure Monitor is manufactured by Shenzhen Jamr Medical Technology Co., Ltd..

What is the FDA product code for Wrist Type Blood Pressure Monitor?

The FDA product code for Wrist Type Blood Pressure Monitor is DXN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

Related Devices (Code: DXN)

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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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