K Number
K962534Device Name
THERA-MIST NEBULIZER MODEL-P3000
Manufacturer
Date Cleared
1997-02-28
(245 days)
Product Code
Regulation Number
868.5630AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
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§ 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).
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