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K Number
K010040
Device Name
SLEEVED FILTER
Manufacturer
KING SYSTEMS CORP.
Date Cleared
2001-03-09

(63 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

The Sleeved Filter or Sleeved HME/Fitter is used to reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.

Device Description

Sleeved Filter, Sleeved HME/Filter.

AI/ML Overview

This is a marketing clearance letter for a medical device submitted to the FDA. It does not contain information about the acceptance criteria and study results for an AI/ML device. Therefore, I cannot extract the requested information from the provided text.

§ 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).