Devilbiss DV5M Smartlink System
FDA 510(k) K082209 · Sunrise Medical
510(k) numberK082209
Submission
- Device name
- Devilbiss DV5M Smartlink System
- Applicant
- Sunrise Medical
Somerset, PA, US - Received
- August 5, 2008
- Decision date
- October 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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| 510(k) | Device | Decision |
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| K123975 | Quickie & Zippie SeriesIOR · Traditional | 08/16/2013SE |
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| K091919 | Devilbiss Intellipap/Sleepcube Bilevel S/StBZD · Traditional | 09/28/2009SE |
| K081468 | Devilbiss Portable Oxygen Concentrator, 306 SeriesCAW · Traditional | 08/25/2008SE |
| K071397 | Devilbiss 5 Liter Compact Oxygen Concentrator, Model 525 SeriesCAW · Special | 10/01/2007SE |
| K072153 | Quickie QX Manual Folding WheelchairIOR · Traditional | 09/10/2007SE |
| K071689 | Devilbiss Intellipap Model DV 5 SeriesBZD · Traditional | 09/07/2007SE |
| K062701 | Quickie Rhapsody, MWD Series II Power WheelchairITI · Special | 09/25/2006SE |
| K060531 | Quickie Rhythm & Groove Series Power Wheelchairs W/Quickie Delphi ControlsITI · Special | 03/17/2006SE |
| K053240 | Devilbiss Oxygen Cylinder Filling System, 535 SeriesCAW · Traditional | 02/03/2006SE |
Questions and answers
When was Devilbiss DV5M Smartlink System cleared by the FDA?
Devilbiss DV5M Smartlink System (K082209) received a 510(k) decision of Substantially Equivalent on October 28, 2008, 84 days after the submission was received.
What is the product code of K082209?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.