Spacelabs Medical Multiparameter Module 91496

• • Terminated Z-0523-2007 FDA Unclassified (pre-2012) ·initiated 3 Jan 2007

  Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment.

510(k) Number

K050605 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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