Besmed Reusable Jet Nebulizer
FDA 510(k) K150591 · Besmed Health Business Corp
510(k) numberK150591
Submission
- Device name
- Besmed Reusable Jet Nebulizer
- Applicant
- Besmed Health Business Corp
New Taipei City, TW - Received
- March 9, 2015
- Decision date
- June 30, 2015
- 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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| K242354 | AllNEBCAF · Traditional | Enchant Tek Co. , Ltd. | 04/29/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | 11/14/2024SE |
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| K160112 | Besmed PEEP ValveBYE · Traditional | 04/29/2016SE |
| K143150 | CO2 monitoring line with and without in-line filterCCK · Traditional | 02/05/2015SE |
| K141355 | Volumetric Incentive SpirometerBWF · Traditional | 09/03/2014SE |
| K140370 | Disposable Pressure ManometerCAP · Traditional | 06/19/2014SE |
| K133873 | Triball Incentive SpirometerBWF · Traditional | 04/04/2014SE |
| K091272 | Besmed Jet Nebulizer Bottle SetCAF · Traditional | 11/10/2009SE |
| K031374 | Besmed Various Models of TENS, BE-550/BE-660GZJ · Traditional | 11/28/2003SE |
| K031375 | Besmed Various Models of Powered Muscle Stimulator, BE-560/BE-580IPF · Traditional | 11/20/2003SE |
Questions and answers
When was Besmed Reusable Jet Nebulizer cleared by the FDA?
Besmed Reusable Jet Nebulizer (K150591) received a 510(k) decision of Substantially Equivalent on June 30, 2015, 113 days after the submission was received.
What is the product code of K150591?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.