Aerosol System
FDA 510(k) K063716 · Amici, Inc.
510(k) numberK063716
Submission
- Device name
- Aerosol System
- Applicant
- Amici, Inc.
Spring City, PA, US - Received
- December 14, 2006
- Decision date
- December 28, 2007
- 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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| K251572 | eRapid with eTrack SystemCAF · Traditional | Pari Respiratory Equipment, Inc. | 12/19/2025SE |
| K251659 | Mesh Nebulizer (H6)CAF · Traditional | Qingdao Future Medical Technology Co., Ltd. | 11/14/2025SE |
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| K250022 | HeroTracker SenseCAF · Traditional | Voluntis | 06/30/2025SE |
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| K242354 | AllNEBCAF · Traditional | Enchant Tek Co. , Ltd. | 04/29/2025SE |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | Thayer Medical Corporation | 06/18/2024SE |
| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
More from Aerogen, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K952910 | The Swirler NebulizerCAF · Traditional | 03/19/1997SE |
| K952893 | The Swirler Aerosol SystemCAF · Traditional | 11/03/1995SE |
| K904684 | Amici Krypton Administration System, ModificationIYT · Traditional | 01/14/1991SE |
| K903805 | Amici Xenon Administration SetIYT · Traditional | 01/14/1991SE |
| K903694 | Amici Tru-Fit Soft Plastic MouthpieceIYT · Traditional | 10/03/1990SE |
| K872920 | Amici Krypton Administration System*IYT · Traditional | 02/12/1988SE |
| K865084 | Amici Xenon Rebreathing System*IYT · Traditional | 03/03/1987SE |
Questions and answers
When was Aerosol System cleared by the FDA?
Aerosol System (K063716) received a 510(k) decision of Substantially Equivalent on December 28, 2007, 379 days after the submission was received.
What is the product code of K063716?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.