Continuous Nebulization Tube Set (CNTS) Tubing: AG-AS3075 + Syringe: AG-AS3085; Continous Nebulization Tube Set (CNTS) S
FDA 510(k) K103635 · Aerogen, Ltd.
510(k) numberK103635
Submission
- Device name
- Continuous Nebulization Tube Set (CNTS) Tubing: AG-AS3075 + Syringe: AG-AS3085; Continous Nebulization Tube Set (CNTS) S
- Applicant
- Aerogen, Ltd.
Galway, IE - Received
- December 13, 2010
- Decision date
- May 13, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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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| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | Thayer Medical Corporation | 06/18/2024SE |
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More from Aerogen, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251615 | Aerogen Pro-X1 Controller SystemSFP · Traditional | 09/02/2025SE |
| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | 05/10/2024SE |
| K143719 | Aeroneb USB Contoller SystemCAF · Traditional | 07/10/2015SE |
| K133360 | Aeroneb Solo; Aeroneb Solo AdapterCAF · Traditional | 10/17/2014SE |
| K120939 | Aeroneb ProCAF · Special | 04/26/2012SE |
| 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 Continuous Nebulization Tube Set (CNTS) Tubing: AG-AS3075 + Syringe: AG-AS3085; Continous Nebulization Tube Set (CNTS) S cleared by the FDA?
Continuous Nebulization Tube Set (CNTS) Tubing: AG-AS3075 + Syringe: AG-AS3085; Continous Nebulization Tube Set (CNTS) S (K103635) received a 510(k) decision of Substantially Equivalent on May 13, 2011, 151 days after the submission was received.
What is the product code of K103635?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.