LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70
FDA 510(k) K963924 · Pari Holding Co.
510(k) numberK963924
Submission
- Device name
- LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70
- Applicant
- Pari Holding Co.
Richmond, VA, US - Received
- September 30, 1996
- Decision date
- December 10, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| 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 |
| K244035 | Portable mesh nebulizer (JM821)CAF · Traditional | Shenzhen Jermei Medical Device Technology Co.… | 09/19/2025SE |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer…CAF · Traditional | Joytech Healthcare Co. , Ltd. | 07/02/2025SE |
| K250022 | HeroTracker SenseCAF · Traditional | Voluntis | 06/30/2025SE |
| K250583 | AdheResp Smart Breath-actuated Mesh NebulizerCAF · Traditional | Hcmed Innovations Co., Ltd. | 06/20/2025SE |
| 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 |
|---|---|---|
| K002862 | Proneb Ultra Model Number 85B0100BTI · Traditional | 03/13/2001SE |
| K983308 | RC Cornet, Model #44F50BWF · Traditional | 06/04/1999SE |
| K972042 | Pari Pep Therapy SystemBWF · Traditional | 08/05/1997SE |
| K962072 | Proneb Turbo Compressor Model 38V0200CAF · Traditional | 08/21/1996SE |
| K960675 | Walkhaler Portable Compressor Model 45F70CAF · Traditional | 05/17/1996SE |
| K935540 | Pari-Master ModificationCAF · Traditional | 03/17/1995SE |
| K944152 | Pari BabyCAF · Traditional | 11/18/1994SE |
Questions and answers
When was LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70 cleared by the FDA?
LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70 (K963924) received a 510(k) decision of Substantially Equivalent on December 10, 1996, 71 days after the submission was received.
What is the product code of K963924?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.