Cleared Traditional

DeVilbiss DV6WM Wireless Modem

K152810 · Devilbiss Healthcare, LLC · Anesthesiology
Jan 2016
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K152810 is an FDA 510(k) clearance for the DeVilbiss DV6WM Wireless Modem, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Devilbiss Healthcare, LLC (Somerset, US). The FDA issued a Cleared decision on January 21, 2016, 115 days after receiving the submission on September 28, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K152810 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2015
Decision Date January 21, 2016
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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