DeVilbiss DV6WM Wireless Modem
FDA 510(k) K152810 · Devilbiss Healthcare, LLC
510(k) numberK152810
Submission
- Device name
- DeVilbiss DV6WM Wireless Modem
- Applicant
- Devilbiss Healthcare, LLC
Somerset, PA, US - Received
- September 28, 2015
- Decision date
- January 21, 2016
- 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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| K143677 | DeVilbiss Intellipap2/DeVilbiss BLUEBZD · Traditional | 09/18/2015SE |
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Questions and answers
When was DeVilbiss DV6WM Wireless Modem cleared by the FDA?
DeVilbiss DV6WM Wireless Modem (K152810) received a 510(k) decision of Substantially Equivalent on January 21, 2016, 115 days after the submission was received.
What is the product code of K152810?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.