Cleared Traditional

AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER

K051226 · Cardinalhealth · Anesthesiology
Nov 2005
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K051226 is an FDA 510(k) clearance for the AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on November 17, 2005, 189 days after receiving the submission on May 12, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K051226 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2005
Decision Date November 17, 2005
Days to Decision 189 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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