Aerogen®Solo Nebulizer System
FDA 510(k) K232507 · Aerogen, Ltd.
510(k) numberK232507
Submission
- Device name
- Aerogen®Solo Nebulizer System
- Applicant
- Aerogen, Ltd.
Dangan Galway, IE - Received
- August 18, 2023
- Decision date
- May 10, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| K133360 | Aeroneb Solo; Aeroneb Solo AdapterCAF · Traditional | 10/17/2014SE |
| K120939 | Aeroneb ProCAF · Special | 04/26/2012SE |
| K103635 | Continuous Nebulization Tube Set (CNTS) Tubing: AG-AS3075 + Syringe: AG-AS3085…CAF · Special | 05/13/2011SE |
| K032849 | Aeroneb Go Nebulizer, Model AG-AG2000CAF · Traditional | 11/21/2003SE |
| K021175 | Aeroneb Professional Nebulizer System, MODEL#AG-AP6000CAF · Traditional | 05/15/2002SE |
| K003022 | Aeroneb Portable NebulizerCAF · Traditional | 10/13/2000SE |
| K992831 | Aeroneb II, Model Apn 200CAF · Traditional | 08/25/2000SE |
Questions and answers
When was Aerogen®Solo Nebulizer System cleared by the FDA?
Aerogen®Solo Nebulizer System (K232507) received a 510(k) decision of Substantially Equivalent on May 10, 2024, 266 days after the submission was received.
What is the product code of K232507?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.