Search Results
Found 2 results
510(k) Data Aggregation
K Number
K081650Device Name
AERONEB GO NEBULIZER
Manufacturer
AEROGEN (IRELAND) LTD
Date Cleared
2008-10-23
(133 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
AEROGEN (IRELAND) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aeroneb® Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.
Device Description
Not Found
Ask a Question
K Number
K070642Device Name
AERONEB PROFESSIONAL NEBULIZER SYSTEM
Manufacturer
AEROGEN (IRELAND) LTD
Date Cleared
2007-05-07
(60 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
AEROGEN (IRELAND) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb® Professional Nebulizer System is suitable for use in adult and pediatric patients as described in the Instruction Manual.
Device Description
The Aeroneb® Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance.
Ask a Question
Page 1 of 1