Portable Lifecare Ventilator Plv-100

• 2 recalls, same reason

  • Terminated Z-2345-2008 FDA Unclassified (pre-2012) ·initiated 8 Jul 2008
  • Terminated Z-2344-2008 FDA Unclassified (pre-2012) ·initiated 8 Jul 2008

  Certain PLV-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure.

510(k) Number

K832467 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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