Devilbiss Model 5500
FDA 510(k) K946095 · Devilbiss Health Care, Inc.
510(k) numberK946095
Submission
- Device name
- Devilbiss Model 5500
- Applicant
- Devilbiss Health Care, Inc.
Somerset, PA, US - Received
- December 14, 1994
- Decision date
- August 24, 1995
- 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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| 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 |
|---|---|---|
| K963349 | Devilbiss 8650DBTI · Traditional | 06/13/1997SE |
| K970289 | Compressor/Nebulizer #3650CAF · Traditional | 04/15/1997SE |
| K961126 | Pulse Dose SeriesNFB · Traditional | 10/21/1996SE |
| K950849 | Model #7354BZD · Traditional | 02/08/1996SE |
| K952491 | Model 7355BZD · Traditional | 01/31/1996SE |
| K952249 | Jet NebulizerCAF · Traditional | 01/30/1996SE |
| K953815 | 5 LPM Oxygen ConcentratorCAW · Traditional | 11/09/1995SE |
| K952037 | 3 LPM Oxygen ConcentratorCAW · Traditional | 09/06/1995SE |
| K944611 | Model# 7500 SurveyorMNR · Traditional | 04/21/1995SE |
| K935979 | Continuous Positive Airway Pressure CPAP SystemBZD · Traditional | 11/10/1994SE |
Questions and answers
When was Devilbiss Model 5500 cleared by the FDA?
Devilbiss Model 5500 (K946095) received a 510(k) decision of Substantially Equivalent on August 24, 1995, 253 days after the submission was received.
What is the product code of K946095?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.