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K Number
K013856
Device Name
PMH 1000 HEATED HUMIDIFIER
Manufacturer
PEGASUS RESEARCH CORP.
Date Cleared
2003-02-21

(472 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

The PMH 1000 Heated Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the PMH 1000 Heated Humidifier. This type of document does not contain the information requested about acceptance criteria, study details, or ground truth for a device's performance.

The letter confirms that the device is substantially equivalent to a predicate device and can be marketed, subject to general controls. It's a regulatory approval letter, not a technical report or scientific study summary.

Therefore, I cannot extract the requested information from the provided text.

§ 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).