Cleared Traditional

DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL

K112220 · Devilbiss Healthcare, LLC · Anesthesiology
Nov 2011
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K112220 is an FDA 510(k) clearance for the DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL, 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 November 22, 2011, 112 days after receiving the submission on August 2, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K112220 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2011
Decision Date November 22, 2011
Days to Decision 112 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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