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FDA 510(k)

Oscillometric Blood Pressure Monitor

K-Number: K190927 · 2019-06-24

ApplicantRudolf Riester GmbH
Decision Date2019-06-24
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Oscillometric Blood Pressure Monitor is a medical device manufactured by Rudolf Riester GmbH. It received FDA 510(k) clearance on 2019-06-24 under approval number K190927. 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 Oscillometric Blood Pressure Monitor?

Oscillometric Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-06-24. It is manufactured by Rudolf Riester GmbH. The 510(k) number is K190927.

When was Oscillometric Blood Pressure Monitor approved by the FDA?

Oscillometric Blood Pressure Monitor received FDA 510(k) clearance on 2019-06-24, under approval number K190927.

What company makes Oscillometric Blood Pressure Monitor?

Oscillometric Blood Pressure Monitor is manufactured by Rudolf Riester GmbH.

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

The FDA product code for Oscillometric 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)

Other Devices by Rudolf Riester GmbH

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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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