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FDA 510(k)

Digital Blood Pressure Monitor

K-Number: K153033 · 2016-06-24

ApplicantSuzhou Sunspiri Co., Ltd.
Decision Date2016-06-24
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Blood Pressure Monitor is a medical device manufactured by Suzhou Sunspiri Co., Ltd.. It received FDA 510(k) clearance on 2016-06-24 under approval number K153033. 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?

Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Suzhou Sunspiri Co., Ltd.. The 510(k) number is K153033.

When was Digital Blood Pressure Monitor approved by the FDA?

Digital Blood Pressure Monitor received FDA 510(k) clearance on 2016-06-24, under approval number K153033.

What company makes Digital Blood Pressure Monitor?

Digital Blood Pressure Monitor is manufactured by Suzhou Sunspiri Co., Ltd..

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

The FDA product code for Digital 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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