LogoFDA 510(k) Search
K Number
K132679
Device Name
AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER
Manufacturer
GALEMED CORP.
Date Cleared
2014-04-18

(233 days)

Product Code
CAH
Regulation Number
868.5260
Type
Traditional
Panel
HO
Reference & 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).