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K Number
K983783
Device Name
HEATED HUMIDIFIER
Manufacturer
PEGASUS RESEARCH CORP.
Date Cleared
2000-10-24

(728 days)

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

The Patient End Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for a "Heated Humidifier" with the device name "PATIENT-END HUMIDIFIER" (K983783). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter is an FDA clearance, stating the device is substantially equivalent to a predicate device, which allows it to be marketed.

Therefore, I cannot provide the requested information based on this document.

§ 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).