Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RVS-100 Vital Signs Monitor

K-Number: K170538 · 2017-10-17

ApplicantRudolf Riester GmbH
Decision Date2017-10-17
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RVS-100 Vital Signs Monitor is a medical device manufactured by Rudolf Riester GmbH. It received FDA 510(k) clearance on 2017-10-17 under approval number K170538. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RVS-100 Vital Signs Monitor?

RVS-100 Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2017-10-17. It is manufactured by Rudolf Riester GmbH. The 510(k) number is K170538.

When was RVS-100 Vital Signs Monitor approved by the FDA?

RVS-100 Vital Signs Monitor received FDA 510(k) clearance on 2017-10-17, under approval number K170538.

What company makes RVS-100 Vital Signs Monitor?

RVS-100 Vital Signs Monitor is manufactured by Rudolf Riester GmbH.

What is the FDA product code for RVS-100 Vital Signs Monitor?

The FDA product code for RVS-100 Vital Signs Monitor is MWI.

Related Clinical Trials

NCT06561828 Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making RECRUITING NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT07614607 Evaluating the Efficacy and Utility of the Automated Pupillometer in Pain Assessment and Opioid Administration Guidance During the Perioperative Period: A Randomized Controlled Trial ACTIVE_NOT_RECRUITING NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION

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: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Other Devices by Rudolf Riester GmbH

K171182ri-former Predictive Thermometer K190927Oscillometric Blood Pressure Monitor

Related Devices (Code: MWI)

K161909IQvitals ZoneMidmark Corporation K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien K151839AMC Health VitalCaregiving SystemAmc Health K160956LD-Oxi systemLd Technology, LLC K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation

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.

↑