FDA.reportPublic FDA data

Aerogen Shannon

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30180708433018070843Aerogen Shannon1N2026-01-01Shannon Industrial Estate Shannon Co. Clare Clare IE V14HN40

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2890441015625889K251615Aerogen Pro-X1 Controller SystemSFP2025-09-02
2890441293595364K232507Aerogen®Solo Nebulizer SystemCAF2024-05-10
2890441682978327K070642AERONEB PROFESSIONAL NEBULIZER SYSTEMCAF2007-05-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAF22024-05-10
SFP12025-09-02