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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 the device name listed in this FDA 510(k) record. The listed applicant is Rudolf Riester GmbH. It received FDA 510(k) clearance on 2019-06-24 under 510(k) 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. The listed applicant is Rudolf Riester GmbH. The 510(k) number is K190927.

When did Oscillometric Blood Pressure Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for Oscillometric Blood Pressure Monitor?

The FDA 510(k) record lists Rudolf Riester GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07240831Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)RECRUITING

Related PubMed Literature

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.

PMID: 40388896Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates.Neonatology (2025)

Other records listing Rudolf Riester GmbH as applicant

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.

K170538RVS-100 Vital Signs MonitorK171182ri-former Predictive Thermometer

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.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.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 GmbH

Official Source

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