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K Number
K962822

Validate with FDA (Live)

Device Name
OPTICHAMBER
Manufacturer
HEALTHSCAN PRODUCTS, INC.
Date Cleared
1996-10-17

(90 days)

Product Code
CAF
Regulation Number
868.5630
Type
Traditional
Panel
Anesthesiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K042546,K072418,K100285,K110136
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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).