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510(k) Data Aggregation
K Number
K021443Device Name
56 SERIES JET NEBULIZER
Manufacturer
PROJECT MARKETING
Date Cleared
2002-10-21
(168 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PROJECT MARKETING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 56 Series Jet Nebulizer is a pneumatic nebulizer, which nebulizes specific drugs for inhalation by a patient.
Device Description
The 56 Series Jet Nebulizer is a pneumatic nebulizer, which nebulizes specific drugs for inhalation by a patient.
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K Number
K980074Device Name
56 SERIES AEROSOL GENERATOR
Manufacturer
PROJECT MARKETING
Date Cleared
1998-06-12
(155 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PROJECT MARKETING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 56 series Aerosol Generator is for the production of compressed air to operate a nebulizer for the production of medical aerosol for respiratory disorders. The 56 series Aerosol Generator requires a nebulizer and medication for operation. The use of the 56 series Aerosol Generator is for the sole purpose of compressed air production and requires the order of a physician for medical use.
Device Description
Not Found
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