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)

Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s

K-Number: K202892 · 2021-01-28

ApplicantEdan Instruments, Inc.
Decision Date2021-01-28
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2021-01-28 under approval number K202892. 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 Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s?

Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s is a medical device that received FDA 510(k) clearance on 2021-01-28. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K202892.

When was Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s approved by the FDA?

Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s received FDA 510(k) clearance on 2021-01-28, under approval number K202892.

What company makes Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s?

Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s is manufactured by Edan Instruments, Inc..

What is the FDA product code for Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s?

The FDA product code for Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s 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for Learning and Decision-Making RECRUITING NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT07614607 Evaluating the Efficacy and Utility of the Automated Pupillometer in Pain Assessment and Opioid Administration Guidance During the Perioperative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)

Other Devices by Edan Instruments, Inc.

K160981Patient Monitor K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control K161302PC ECG K161300Acclarix AX8 Diagnostic Ultrasound System K152552Patient Monitor K160790Acclarix LX8 Diagnostic Ultrasound System

View all 48 devices →

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.

↑