800 Series Easyneb Nebulizer

• • Terminated Z-0611-2014 FDA Class I ·initiated 16 Dec 2013 ·on shared 510(k) K020357

  Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K020357 ↗

FDA Product Code

CAF

Device Class

Class II

Regulation

21 CFR Part 868.5630

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K963400 Active Cleared 26 Nov 1996

• Npb-290 Pulse Oximeter (Npb-290)

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

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  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. →