K Number
K011132Device Name
AIRLIFE HEPA FILTERManufacturer
Date Cleared
2001-06-08
(56 days)
Product Code
Regulation Number
868.5260Type
SpecialPanel
HOReference & Predicate Devices
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).