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K Number
K964204

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Device Name
ENGSTROM HMEF 1000
Manufacturer
DATEX ENGSTROM AB
Date Cleared
1996-11-13

(76 days)

Product Code
CAH
Regulation Number
868.5260
Type
Traditional
Panel
General Hospital
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K021265,K130664
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).