FDA.reportPublic FDA data

AEROGEN LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30033997033003399703AEROGEN LTD1N2027-01-01GALWAY BUSINESS PARK DANGAN Galway(County) IE --

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
842081015625889K251615Aerogen Pro-X1 Controller SystemSFP2025-09-02
842081293595364K232507Aerogen®Solo Nebulizer SystemCAF2024-05-10
842082063154463K143719Aeroneb USB Contoller SystemCAF2015-07-10
842081603702472K133360AERONEB SOLO; AERONEB SOLO ADAPTERCAF2014-10-17
842081200335151K103635CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) SCAF2011-05-13
842081190907403K102240NIVO NEBULIZER SYSTEMCAF2010-11-10
842081426983255K081650AERONEB GO NEBULIZERCAF2008-10-23
842081682978327K070642AERONEB PROFESSIONAL NEBULIZER SYSTEMCAF2007-05-07
842081675647049K030271VENTLAB BACTERIAL FILTER, MODEL BF100CAH2003-07-07
842081783479213K021175AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000CAF2002-05-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAF82024-05-10
SFP12025-09-02
CAH12003-07-07

PMN#