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K Number
K963917
Device Name
HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT
Manufacturer
HOLDEN WALKER CORP.
Date Cleared
1997-02-25

(148 days)

Product Code
CAF
Regulation Number
868.5630
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).