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K Number
K010680
Device Name
CT SPACER
Manufacturer
CLINICAL TECHNOLOGIES, INC.
Date Cleared
2001-05-23

(77 days)

Product Code
CAF
Regulation Number
868.5630
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
N/A
Predicate For
K091862,K101136
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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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).