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K Number
K011212

Validate with FDA (Live)

Device Name
FILTERFLO H
Manufacturer
ARC MEDICAL, INC.
Date Cleared
2001-12-20

(244 days)

Product Code
CAH
Regulation Number
868.5260
Type
Traditional
Panel
General Hospital
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K013089,K014281
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).