Devilbiss 5 Liter Oxygen Concentrator

• • Terminated Z-0617-2009 FDA Unclassified (pre-2012) ·initiated 30 Oct 2008

  potential for sieve beds to have been incorrectly assembled

510(k) Number

K991722 ↗

FDA Product Code

CAW

Device Class

Class II

Regulation

21 CFR Part 868.5440

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 PD1000

  Class II

  FDA 510(k) K020329 Active Cleared 19 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

See all devices from Sunrise Medical Hhg, Inc. →

• What is the primary function of the Devilbiss 5 Liter Oxygen Concentrator?

  This device is a portable oxygen generator designed to provide a continuous supply of oxygen to the user.

• Is this device authorized for use?

  Yes, the Devilbiss 5 Liter Oxygen Concentrator is authorized under FDA 510k clearance, which signifies it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

• What regulatory classification does this device fall under?

  The device is categorized under regulation number 868.5440, which pertains to portable oxygen generators within the anesthesiology medical specialty.