Cleared Traditional

VPAP ADAPT

K113801 · ResMed Corp · Anesthesiology
May 2012
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K113801 is an FDA 510(k) clearance for the VPAP ADAPT, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on May 25, 2012, 155 days after receiving the submission on December 22, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K113801 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2011
Decision Date May 25, 2012
Days to Decision 155 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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