Devilbiss Smartlink II System
FDA 510(k) K140880 · Devilbiss Healthcare, LLC
510(k) numberK140880
Submission
- Device name
- Devilbiss Smartlink II System
- Applicant
- Devilbiss Healthcare, LLC
Somerset, PA, US - Received
- April 7, 2014
- Decision date
- August 4, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional | 03/26/2026SE |
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| K172648 | Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorCAW · Traditional | 03/23/2018SE |
| K152810 | DeVilbiss DV6WM Wireless ModemBZD · Traditional | 01/21/2016SE |
| K143677 | DeVilbiss Intellipap2/DeVilbiss BLUEBZD · Traditional | 09/18/2015SE |
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Questions and answers
When was Devilbiss Smartlink II System cleared by the FDA?
Devilbiss Smartlink II System (K140880) received a 510(k) decision of Substantially Equivalent on August 4, 2014, 119 days after the submission was received.
What is the product code of K140880?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.