Draeger Medical Information Bus (mib, Mib Ii, Mib Duo) Protocol Converters
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050974 FDA 510(k)
- FDA Product Code
- DRQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2060 FDA 510(k)
- Regulation Number
- 870.2060 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Draeger Medical Information Bus Protocol Converters are devices that enable connectivity between third-party medical devices and Infinity Modular Monitors for displaying patient data. These converters utilize the Medical Information Bus (MIB) IEEE 1073 Standard to interface with various point-of-care devices such as ventilators, incubators, and anesthesia systems.
The protocol converters are intended for use in healthcare settings where patient care is provided by professionals including physicians, nurses, and technicians. They are supplied as part of the device connectivity options for Infinity patient monitors and are designed to display data from connected devices on the monitor screen. The device has received FDA 510(k) clearance with product code DRQ and is classified as an amplifier and signal conditioner, transducer signal.
Frequently asked questions
What is the purpose of Draeger Medical Information Bus Protocol Converters?
These converters enable connectivity between third-party medical devices and Infinity Modular Monitors, allowing patient data from devices like ventilators, incubators, and anesthesia systems to be displayed on the monitor screen.
How are the Draeger Medical Information Bus Protocol Converters supplied?
The converters are supplied as part of the device connectivity options for Infinity patient monitors, designed to integrate seamlessly with existing healthcare monitoring systems.
What regulatory status do the Draeger Medical Information Bus Protocol Converters have?
The device has received FDA 510(k) clearance with product code DRQ and is classified as an amplifier and signal conditioner, transducer signal.
What types of medical devices can connect to the Draeger Medical Information Bus Protocol Converters?
The converters utilize the Medical Information Bus (MIB) IEEE 1073 Standard to interface with various point-of-care devices including ventilators, incubators, and anesthesia systems.
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: Draeger Medical Information Bus (Mib, Mib Ii, Mib Duo) Protocol ..., Device Connectivity Option (MIB) | Draeger, PDF Device Connectivity Option (MIB) Pods, Modules and Options
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050974 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA 510(k) K050974 24 fields · synced Oct 6, 2026