Medical Device Manufacturer · IE , Galway

Aerogen, Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2011

Recent clearances: Aerogen Pro-X1 Controller System, Aerogen®Solo Nebulizer System

5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - Aerogen, Ltd. Anesthesiology ✕

5 devices
1-5 of 5
Cleared Sep 02, 2025
Aerogen Pro-X1 Controller System
K251615 · SFP
Anesthesiology · 98d
Cleared May 10, 2024
Aerogen®Solo Nebulizer System
K232507 · CAF
Anesthesiology · 266d
Cleared Oct 17, 2014
AERONEB SOLO
K133360 · CAF
Anesthesiology · 350d
Cleared Apr 26, 2012
AERONEB PRO
K120939 · CAF
Anesthesiology · 28d
Cleared May 13, 2011
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085
K103635 · CAF
Anesthesiology · 151d
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