Devilbiss Intellipap/Sleepcube Bilevel S/St

• • 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".

510(k) Number

K091919 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Devilbiss Intellipap Model Dv 5 Series

  Class II

  FDA 510(k) K071689 Active Cleared 7 Sep 2007

• Devilbiss Oxygen Cylinder Filling System 535 Series

  Class II

  FDA 510(k) K053240 Active Cleared 3 Feb 2006

• Quickie Interchange Fwd W/Lift Power Wheelchair

  Class II

  FDA 510(k) K043435 Active Cleared 11 Feb 2005

• Quickie Freestyle Power Wheelchair, Model G-424

  Class II

  FDA 510(k) K031289 Active Cleared 9 May 2003

• Power Recliner

  Class II

  FDA 510(k) K944423 Active Cleared 28 Nov 1994

• Quickie Rhapsody, Mwd Series II Power Wheelchair

  Class II

  FDA 510(k) K062701 Active Cleared 25 Sep 2006

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