Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1015625889
Device Listing 1015625889
Listing Summary
#
Listing key
1015625889
Premarket submission
K251615
Device
Aerogen Pro-X1 Controller System
Applicant
Aerogen, Ltd.
Product code
SFP
Decision date
2025-09-02
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
84208
3003399703
3003399703
Yong Sun
1
N
2026-01-01
2500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746
84209
3004127293
3004127293
AEROGEN LTD.
1
N
2026-01-01
M&M QUALTECH, PARKMORE BUSINESS PARK GALWAY IE --
289044
3018070843
3018070843
Yong Sun
1
N
2026-01-01
2500 Bee Cave Rd. Bldg. 1, Ste. 300 Austin TX US 78746