Servoi Ventilator System, Model 64 87 800 E407E

• • Terminated Z-0372-2007 FDA Unclassified (pre-2012) ·initiated 23 May 2006

  Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.

510(k) Number

K010925 ↗

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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