Cleared Traditional

DeVilbiss Intellipap2/DeVilbiss BLUE

K143677 · Devilbiss Healthcare, LLC · Anesthesiology
Sep 2015
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K143677 is an FDA 510(k) clearance for the DeVilbiss Intellipap2/DeVilbiss BLUE, 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 September 18, 2015, 268 days after receiving the submission on December 24, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K143677 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 2014
Decision Date September 18, 2015
Days to Decision 268 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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