VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM

• K Number: K935778
• Device Name: VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM
• Manufacturer: VIA MEDICAL CORP.
• Date Cleared: 1996-12-05 ( 1098 days)
• Product Code: CCE CCC LZF
• Regulation Number: 868.1200

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

§ 868.1200 Indwelling blood oxygen partial pressure (P

O2 ) analyzer.(a)
Identification. An indwelling blood oxygen partial pressure (PO2 ) analyzer is a device that consists of a catheter-tip PO2 transducer (e.g., PO2 electrode) and that is used to measure, in vivo, the partial pressure of oxygen 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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