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510(k) Data Aggregation
K Number
K162041Device Name
Airworks Nebulizer pe1200m
Manufacturer
Convexity Scientific LLC
Date Cleared
2017-05-02
(281 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
Convexity Scientific LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Airworks™ Nebulizer pel 200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer. Airworks™ Nebulizer pe1200m is intended for use at home or a medical facility, such as a hospital or doctor's office.
Device Description
The Airworks™ Nebulizer pe1200m, for use by adolescent and adult patients, is intended to aerosolize healthcare provider-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
The Airworks™ Nebulizer pe1200m uses a vibrating mesh technology, which is comprised of a medicalgrade stainless steel disk containing 1,000 precision-formed holes. When energy is applied, the disk vibrates approximately 110,000 times per second. This rapid vibration causes a difference in pressure on either side of each aperture, drawing liquid through the holes to form consistently sized droplets.
The Airworks™ Nebulizer pe1200m is lightweight, compact and virtually silent. A rechargeable lithiumion battery powers the device.
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