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K Number
K960359

Validate with FDA (Live)

Device Name
ALADDIN MONITORING OXYGEN/AIR MIXER
Manufacturer
HAMILTON MEDICAL, INC.
Date Cleared
1996-04-24

(90 days)

Product Code
BZR
Regulation Number
868.5330
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K012034,K984254
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 868.5330 Breathing gas mixer.

(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).