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K Number
K001137
Device Name
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
Manufacturer
TRUDELL MEDICAL INT'L
Date Cleared
2000-07-05

(86 days)

Product Code
CAF
Regulation Number
868.5630
Type
Special
Panel
AN
Reference & Predicate Devices
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).