LogoFDA 510(k) Search
K Number
K963924

Validate with FDA (Live)

Device Name
LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70
Manufacturer
PARI HOLDING CO.
Date Cleared
1996-12-10

(71 days)

Product Code
CAF
Regulation Number
868.5630
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K032170,K032849,K033833,K060399,K061381,K062158,K062484,K082541,K100380,K112859
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 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).