MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER

• K Number: K002613
• Device Name: MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
• Manufacturer: NOVA BIOMEDICAL CORP.
• Date Cleared: 2000-10-19 ( 58 days)
• Product Code: CHL , CEM , CGA , CGZ , GJS , GKR , JFP , JIX , JPI
• Regulation Number: 862.1120
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.