Porous Media Humidiflow Humidifier for Universal Humidification

• • Terminated Z-0935-2007 FDA Unclassified (pre-2012) ·initiated 26 Apr 2007

  The Intake filter of the Humidiflow kits may became detached from the module and fall onto the compressor cooling fan during patient treatment. (If the filter were to come in contact with the fan blades this could stop the fan from operating and cause the concentrator to overheat and interrupt the flow of oxygen to the patient)

510(k) Number

K062091 ↗

FDA Product Code

BTT

Device Class

Class II

Regulation

21 CFR Part 868.5450

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Porous Media DPB30 Series Disposable Pre-Bypass Filter

  Class II

  FDA 510(k) K990276 Active Cleared 1 Oct 1999

• Porous Media DBF23 Disposable Respiratory Filter

  Class II

  FDA 510(k) K964979 Active Cleared 11 Mar 1997

• Porous Media DEF25 Disposable Respiratory Filter

  Class II

  FDA 510(k) K982127 Active Cleared 23 Jun 1998

• Porous Media DBF23-R Reusable Respiratory Filter

  Class II

  FDA 510(k) K952428 Active Cleared 7 Jul 1995

• Porous Media DBF23 Reusable Respiratory Filter

  Class II

  FDA 510(k) K965020 Active Cleared 14 Mar 1997

• Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47

  Class II

  FDA 510(k) K061426 Active Cleared 5 Jun 2006

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