RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM

• K Number: K011238
• Device Name: RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
• Manufacturer: METRACOR TECHNOLOGIES, INC.
• Date Cleared: 2002-01-08 ( 260 days)
• Product Code: LZF
• Regulation Number: 880.5725

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).

Summary

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