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FDA 510(k)

RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope

K-Number: K190902 · 2019-05-22

ApplicantWenzhou Renhua Instruments Co., Ltd.
Decision Date2019-05-22
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope is a medical device manufactured by Wenzhou Renhua Instruments Co., Ltd.. It received FDA 510(k) clearance on 2019-05-22 under approval number K190902. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope?

RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope is a medical device that received FDA 510(k) clearance on 2019-05-22. It is manufactured by Wenzhou Renhua Instruments Co., Ltd.. The 510(k) number is K190902.

When was RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope approved by the FDA?

RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope received FDA 510(k) clearance on 2019-05-22, under approval number K190902.

What company makes RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope?

RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope is manufactured by Wenzhou Renhua Instruments Co., Ltd..

What is the FDA product code for RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope?

The FDA product code for RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope is DXQ.

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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: DXQ)

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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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