Devilbiss PD1000

• 2 recalls, same reason

  • Terminated Z-0732-2007 FDA Unclassified (pre-2012) ·initiated 24 Jan 2007
  • Terminated Z-0731-2007 FDA Unclassified (pre-2012) ·initiated 24 Jan 2007

  Cylinder could lose oxygen at high pressure after the filling process

510(k) Number

K020329 ↗

FDA Product Code

NFB

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Devilbiss Model 9200D Heated Humidifier System

  Class II

  FDA 510(k) K020900 Active Cleared 3 Jun 2002

• Devilbiss Model 6305D Heavy Duty Ac Aspirator

  Class II

  FDA 510(k) K981602 Active Cleared 17 Jul 1998

• Devilbiss Humidifier

  Class II

  FDA 510(k) K003626 Active Cleared 4 May 2001

• DeVilbiss Suction Unit

  Class II

  FDA 510(k) K982304 Active Cleared 25 Sep 1998

• Devilbiss 9000 Series Cpap, Model 9001

  Class II

  FDA 510(k) K011229 Active Cleared 11 Jul 2001

• Devilbiss 5 Liter Oxygen Concentrator

  Class II

  FDA 510(k) K991722 Active Cleared 3 Nov 1999

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