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K Number
K052615
Device Name
MEDISIZE GOLD
Manufacturer
MEDISIZE BV
Date Cleared
2005-12-09

(77 days)

Product Code
BTT
Regulation Number
868.5450
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. The Heat and Moisture Exchanger (HME) of the Medisize Gold is intended for passive humidification during anaesthesia and respiratory care.
    1. The integrated booster ability makes it possible to feed additional heat and moisture into the system during respiratory care, specifically, when the use of an HME alone is no longer adequate due to the patients moisture deficit.
Device Description

Not Found

AI/ML Overview

This is a Medical Device 510(k) Premarket Notification from the FDA to Medisize BV regarding their "Medisize Gold" Respiratory Gas Humidifier. It confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

While the document refers to product performance and regulatory compliance, it does not contain the acceptance criteria or the study data proving the device meets those criteria. This type of information would typically be found in the manufacturer's submission package to the FDA, not in the FDA's clearance letter itself.

Therefore, I cannot provide the requested information from the provided text. The document is an approval letter, not a technical report on device performance.

§ 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).