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Model 6000 Two Parameter Bedside Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091787

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K091787 FDA 510(k)
FDA Product Code
DQA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Model 6000 Two Parameter Bedside Monitor is a Class II medical device classified as an Oximeter, designed for continuous noninvasive monitoring of oxygen saturation (SpO₂) and end-tidal carbon dioxide (EtCO₂). It integrates commercially available pulse oximetry and capnography modules to provide real-time waveform and numerical data on a color TFT LCD display, enabling bedside patient assessment in clinical settings.

This device is intended for single-use or reusable application in acute care environments, such as hospitals and intensive care units, where real-time respiratory and oxygenation monitoring is critical. Supplied as a standalone unit, it transmits data wirelessly via 802.11a-g protocol for integration with hospital information systems. The Model 6000 holds FDA 510(k) clearance (K091787) under the Substantially Equivalent (SESE) determination, adhering to regulatory standards for cardiovascular monitoring devices.

Frequently asked questions

What clinical parameters does the Model 6000 monitor, and how does it display the data?

The Model 6000 monitors two key parameters: oxygen saturation (SpO₂) via pulse oximetry and end-tidal carbon dioxide (EtCO₂) through capnography. It integrates commercially available modules for these functions and presents real-time waveform and numerical data on a color TFT LCD display, allowing clinicians to assess respiratory and oxygenation status at the bedside.

Is the Model 6000 designed for single-use or reusable applications, and where is it typically used?

The Model 6000 is intended for both single-use and reusable applications, making it versatile for acute care settings like hospitals and intensive care units where continuous monitoring is essential. Its design supports integration into environments where real-time respiratory and oxygenation assessment is critical.

How does the Model 6000 connect to hospital systems, and what wireless protocol does it use?

The Model 6000 transmits monitoring data wirelessly to integrate with hospital information systems using the 802.11a-g protocol, enabling seamless data sharing and remote access for clinicians.

What regulatory pathway was followed for FDA clearance of the Model 6000, and what committee reviewed it?

The Model 6000 received FDA clearance via a 510(k) submission under the Substantially Equivalent (SESE) determination, classified under the Cardiovascular advisory committee (CV). The review was conducted through the AN (Anesthesiology) review panel, and the clearance type was traditional.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MODEL 6000 TWO PARAMETER BEDSIDE MONITOR (K091787) — FDA 510 (k ..., MODEL 6000 TWO PARAMETER BEDSIDE MONITOR 510(k) K091787 - fda.report, Model 6000 Two Parameter Bedside Monitor - Beudamed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ivy Biomedical Systems, Inc.

Sources (1)

  • FDA 510(k) K091787 24 fields · synced Sep 18, 2026