K Number
K002543
Device Name
COMOACT ULTRASONIC NEBULIZER, MODEL 3060
Manufacturer
Date Cleared
2001-06-14

(302 days)

Product Code
Regulation Number
868.5630
AI/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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