Devilbiss Model 4650 Compressor Neubulizer
FDA 510(k) K931015 · Devilbiss Health Care, Inc.
510(k) numberK931015
Submission
- Device name
- Devilbiss Model 4650 Compressor Neubulizer
- Applicant
- Devilbiss Health Care, Inc.
Somerset, PA, US - Received
- February 26, 1993
- Decision date
- September 30, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTI – Compressor, Air, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.6250
- Specialty
- Anesthesiology
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More from eVent Medical, 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 |
| K946095 | Devilbiss Model 5500CAF · Traditional | 08/24/1995SE |
| K944611 | Model# 7500 SurveyorMNR · Traditional | 04/21/1995SE |
Questions and answers
When was Devilbiss Model 4650 Compressor Neubulizer cleared by the FDA?
Devilbiss Model 4650 Compressor Neubulizer (K931015) received a 510(k) decision of Substantially Equivalent on September 30, 1993, 216 days after the submission was received.
What is the product code of K931015?
The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.