Aerogen®Solo Nebulizer System
Aerogen, Ltd. · Anesthesiology
Open FDA's page for this record- Third party flag
- N
- City
- Dangan Galway
- Advisory committee description
- Anesthesiology
- Address 1
- Galway Business Park
- Statement or summary
- Summary
- Product code
- CAF
- Applicant
- Aerogen, Ltd.
- Decision date
- 2024-05-10
- Decision code
- SESE
- Country code
- IE
- Device name
- Aerogen®Solo Nebulizer System
- Advisory committee
- AN
- Contact
- Thelma Marley
- K number
- K232507
- Date received
- 2023-08-18
- Review advisory committee
- AN
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Nebulizer (Direct Patient Interface)
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5630
- Device class
- 2
- Registration number
- 3003399703, 3012329712, 8043439, 3010880718, 3017207990, 3030446844, 1317346, 3002806730, 3014916466, 3006547005, 3004056932, 8043316, 3015058854, 3014421917, 8030245, 3023209222, 3015928685, 3007134734, 3008395118, 2518443, 3038562397, 3012971441, 9616567, 1314417, 8022032, 3017858026, 8021995, 3017200972, 3002797442, 3014866140, 3009083745, 1063407, 3005910889, 1313525, 9611045, 3006157842, 1526863, 3010402691, 3013053058, 3003622639 +150 more
- FEI number
- 3003399703, 3012329712, 3010880718, 3017207990, 3030446844, 1317346, 3002806730, 3926, 3014916466, 3006547005, 3004056932, 3015058854, 3014421917, 3003256355, 1000283452, 3023209222, 3015928685, 3007134734, 3008395118, 2518443, 3038562397, 3012971441, 1314417, 3003418980, 3017858026, 3017200972, 3002797442, 3014866140, 3009083745, 3005910889, 3006157842, 1526863, 3010402691, 3013053058, 3003622639, 1417411, 3018070843, 3005569927, 3031369651, 3004727093 +150 more