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K Number
K062664
Device Name
HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004
Manufacturer
APEX MEDICAL CORP.
Date Cleared
2006-12-06

(90 days)

Product Code
BTT
Regulation Number
868.5450
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

HumidCare Heated Humidifier is for use with Apex Medical Corp.'s CPAP 9S-003 system. It is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat that some people may experience.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "HumidCare Heated Humidifier." This document does not contain information regarding acceptance criteria or a study proving the device meets those criteria. It is a regulatory approval letter that confirms substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information.

§ 868.5450 Respiratory gas humidifier.

(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).