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K Number
K000697

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Device Name
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
Manufacturer
ALLEGIANCE HEALTHCARE CORP.
Date Cleared
2000-03-30

(29 days)

Product Code
BZE
Regulation Number
868.5270
Type
Special
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K020332,K040790,K071958,K092256,K151303,K151959
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 868.5270 Breathing system heater.

(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).