Voyage
FDA 510(k) K930949 · Mada Medical Products, Inc.
510(k) numberK930949
Submission
- Device name
- Voyage
- Applicant
- Mada Medical Products, Inc.
Carlstadt, NJ, US - Received
- February 23, 1993
- Decision date
- June 1, 1993
- 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 |
| 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 |
|---|---|---|
| K003862 | Mada WheelchairsIOR · Traditional | 01/12/2001SE |
| K002943 | Wheelchair, Mechanical Series Model 3100IOR · Traditional | 10/23/2000SE |
| K950777 | Oxygen RegulatorCAN · Traditional | 04/14/1995SE |
| K930947 | PromenadeCAF · Traditional | 06/01/1993SE |
| K921611 | Madavac 190BTA · Traditional | 09/09/1992SE |
| K850754 | Medajet XL - Jet InjectorKZE · Traditional | 12/10/1985SE |
| K802426 | RESPO2 Oxygen ConcentratorCAW · Traditional | 10/23/1980SE |
Questions and answers
When was Voyage cleared by the FDA?
Voyage (K930949) received a 510(k) decision of Substantially Equivalent on June 1, 1993, 98 days after the submission was received.
What is the product code of K930949?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.