Puritan Bennett Legendair XL2

• • Ongoing Z-2446-2024 FDA Class I ·initiated 24 Jun 2024

  Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some components in the ventilator gas pathway

510(k) Number

K070899 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Shiley Flextra Tracheostomy Tube

  Class II

  FDA 510(k) K030787 Active Cleared 14 Nov 2003

• Nellcor Symphony N-3000 Patient Monitor with SPO2 and ECG and N-3200 Display/Printer

  Class II

  FDA 510(k) K963400 Active Cleared 26 Nov 1996

• Npb-290 Pulse Oximeter (Npb-290)

  Class II

  FDA 510(k) K972837 Active Cleared 21 Oct 1997

• Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-Al, Max-N, Max-I, Max-P

  Class II

  FDA 510(k) K052186 Active Cleared 10 Nov 2005

• Nellcor Puritan Bennett Achieva Ventilator and Report Generator

  Class II

  FDA 510(k) K990177 Active Cleared 18 Nov 1999

• Nellcor N-200 Pulse Oximeter, Model N-200

  Class II

  FDA 510(k) K022819 Active Cleared 24 Sep 2002

See all devices from Nellcor Puritan Bennett, Inc. →