Spacelabs Medical Multigas Analyzer Module 91518 and Accessories

• • Terminated Z-2902-2011 FDA Unclassified (pre-2012) ·initiated 8 Jun 2011

  Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data.

• • Terminated Z-0660-2008 FDA Unclassified (pre-2012) ·initiated 8 Oct 2007

  Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa.

510(k) Number

K053599 ↗

FDA Product Code

CBR

Device Class

Class II

Regulation

21 CFR Part 868.1700

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Spacelabs Medical, Inc. →