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K Number
K963053
Device Name
9000 SERIES FILTER & FILTER/HME
Manufacturer
ENTERNET MEDICAL, INC.
Date Cleared
1997-02-21

(199 days)

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

§ 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).