Devilbiss Intellipap Model Dv 5 Series

• • Terminated Z-1949-2014 FDA Class III ·initiated 13 May 2014

  A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST".

• • Terminated Z-2990-2011 FDA Unclassified (pre-2012) ·initiated 11 Mar 2011

  Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture.

510(k) Number

K071689 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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