POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM

• K Number: K951094
• Device Name: POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM
• Manufacturer: OPTICAL SENSORS, INC.
• Date Cleared: 1996-01-16 ( 313 days)
• Product Code: CCC
• Regulation Number: 868.1150

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

§ 868.1150 Indwelling blood carbon dioxide partial pressure (P

2CO2 ) analyzer.(a)
Identification. An indwelling blood carbon dioxide partial pressure PCO2 analyzer is a device that consists of a catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, in vivo, the partial pressure of carbon dioxide in blood to aid in determining the patient's circulatory, ventilatory, and metabolic status.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”

Summary

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