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Vital Signs Monitor Model M3B

by Edan Instruments, Inc.

510(k) K101539

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101539 Date24 Nov 2010ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1152-2026 FDA Class II initiated 24 Oct 2025

    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vital Signs Monitor Model M3B is a medical device designed for the non-invasive continuous monitoring of patient vital signs. It provides respiratory system data through integrated SpO2 and CO2 monitoring technologies for both intubated and non-intubated patients.

This device is intended for use in clinical environments to facilitate spot checks and continuous monitoring. It is authorized for distribution under FDA 510k clearance.

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Vital Signs Monitor Model M3B?

    The M3B is designed for the non-invasive continuous monitoring of patient vital signs. It is specifically engineered to provide respiratory system data by utilizing integrated SpO2 and CO2 monitoring technologies.

  • Can this device be used for both intubated and non-intubated patients?

    Yes, the device is designed to support both intubated and non-intubated patients, making it a versatile tool for respiratory monitoring in clinical settings.

  • In what settings is the M3B monitor intended to be used?

    The monitor is intended for use in clinical environments. It is suitable for both spot checks and continuous monitoring applications to assist clinicians in tracking patient status.

  • What is the regulatory status of the Edan Instruments M3B monitor?

    The Vital Signs Monitor Model M3B is authorized for distribution under FDA 510k clearance, which indicates that the device has been found substantially equivalent to legally marketed predicate devices.