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FDA 510(k)

Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s

K-Number: K233038 · 2024-03-08

ApplicantEdan Instruments, Inc.
Decision Date2024-03-08
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2024-03-08 under approval number K233038. 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, Model: iM3s, iM3As, iM3Bs, iHM3s?

Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s is a medical device that received FDA 510(k) clearance on 2024-03-08. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K233038.

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

Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s received FDA 510(k) clearance on 2024-03-08, under approval number K233038.

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

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

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

The FDA product code for Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s is MWI.

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)

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

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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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