Mystique Ultrasonic Nebulizer
FDA 510(k) K983002 · Airsep Corp.
510(k) numberK983002
Submission
- Device name
- Mystique Ultrasonic Nebulizer
- Applicant
- Airsep Corp.
Buffalo, NY, US - Received
- August 28, 1998
- Decision date
- October 16, 1998
- 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
Other 510(k)s with product code CAF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)CAF · Traditional | FindAir Sp. z o.o. | 06/02/2026SE |
| 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 |
|---|---|---|
| K150930 | Deployable Oxygen Generation System-Smaill (DOGS-S)CAW · Traditional | 12/18/2015SE |
| K101154 | Centrox, Reliant, Ultrox, As-D+, As-E, As-G, As-J, As-K and As-LCAW · Traditional | 03/28/2011SE |
| K080348 | Oxiscan II Data Management SystemDQA · Traditional | 10/09/2008SE |
| K020324 | Lifestyle Oxygen ConcentratorCAW · Traditional | 03/13/2002SE |
| K012037 | Healthlife Oxygen Concentrator Model AS009CAW · Traditional | 01/17/2002SE |
| K000963 | Da Vinchi EEG and Emg/Ep SystemsGWF · Traditional | 10/20/2000SE |
| K001579 | Impulse SelectNFB · Traditional | 08/31/2000SE |
| K001467 | Da Vinchi Emg/Ep ISA1004EPGWE · Traditional | 08/01/2000SE |
| K001013 | Monet Acquisition System for EEG and PolysomnographyOLV · Traditional | 05/16/2000SE |
| K992283 | Artisan Acquisition System for EEG and PolysomnographyOLV · Traditional | 08/27/1999SE |
Questions and answers
When was Mystique Ultrasonic Nebulizer cleared by the FDA?
Mystique Ultrasonic Nebulizer (K983002) received a 510(k) decision of Substantially Equivalent on October 16, 1998, 49 days after the submission was received.
What is the product code of K983002?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.