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510(k) Data Aggregation
K Number
K180871Device Name
Portable Nebulizer
Manufacturer
Date Cleared
2018-09-14
(164 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
MicroBase Technology Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Portable Nebulizer (MBPN002) is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.
Device Description
The Portable Nebulizer (MBPN002) is a small, handheld general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
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K Number
K170916Device Name
Portable Nebulizer
Manufacturer
Date Cleared
2017-11-28
(244 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
MicroBase Technology Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatic (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.
Device Description
The Portable Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
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Ask a specific question about this device
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