510(k) K143719
- Device
- Aeroneb USB Contoller System
- Applicant
- Aerogen Limited
- 510(k) number
- K143719
- Product code
- CAF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-07-10
- Date received
- 2014-12-29
- Regulation
- 868.5630
- Classification name
- Nebulizer (direct Patient Interface)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Martin Crehan
- Address
- Galway Business Park, Dangan Galway IE
FDA Registration Numbers#
- 3010131137
- 3003781173
- 3029227324
- 3004443928
- 2515872
- 1417411
- 3008220943
- 3006157842
- 9610861
- 3006547005
- 1000604079
- 3005998497
- 8030245
- 8030673
- 1920664
- 3016445583
- 3005285078
- 3009683397
- 1317346
- 3036830503
- 3005587132
- 3014916466
- 3015058854
- 3031259044
- 2648727
- 3003767629
- 9616567
- 1924066
- 3005862821
- 3013000203
- 3006061749
- 3006467300
- 3012316249
- 3011528328
- 3016731115
- 3034521
- 3010880718
- 8010042
- 3015928685
- 2026894
- 3013440654
- 9710644
- 3038562397
- 3030733800
- 3007740533
- 1417592
- 3007154442
- 3008702754
- 3017303999
- 3029706818
- 3010892830
- 3001034529
- 3033332986
- 3010272829
- 3003829675
- 3007134734
- 9710391
- 8022077
- 3010042047
- 3005440755
- 1024404
- 3006500694
- 1423662
- 3001313714
- 2032112
- 8044169
- 3003622639
- 3013557562
- 3018070843
- 8043316
- 9710567
- 3009327812
- 3011721071
- 3033482477
- 3006783791
- 3005569927
- 3009057691
- 3016360883
- 3020460367
Source Documents#
Other 510(k) Records For Product Code CAF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | 2026-06-02 |
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | 2025-12-19 |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | 2025-11-14 |
| K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | 2025-09-19 |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | Joytech Healthcare Co. , Ltd. | 2025-07-02 |
| K250022 | HeroTracker Sense | Voluntis | 2025-06-30 |
| K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. | 2025-06-20 |
| K242354 | AllNEB | Enchant Tek Co. , Ltd. | 2025-04-29 |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | Thayer Medical Corporation | 2024-06-18 |
| K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. | 2024-05-10 |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | 2024-04-10 |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | Medline Industries, LP | 2024-01-04 |
| K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | 2023-11-27 |
| K230602 | Hudson RCI® TurboMist™ Nebulizer System | Medline Industries, LP | 2023-10-31 |
| K223367 | Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation | 2023-08-30 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases