Speacelabs Multigas Module

• • Terminated Z-2077-2014 FDA Class II ·initiated 18 Jun 2014

  With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.

510(k) Number

K112173 ↗

FDA Product Code

CBR

Device Class

Class II

Regulation

21 CFR Part 868.1700

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• elance Vital Signs Monitor, Central Monitor Software

  Class II

  FDA 510(k) K150329 Active Cleared 5 Nov 2015

• Spacelabs Smart Disclosure System

  Class II

  FDA 510(k) K110779 Active Cleared 19 Apr 2011

• Spacelabs Arkon Anesthesia Workstation

  Class II

  FDA 510(k) K113051 Active Cleared 22 Mar 2012

• Capnography Pad (92516)

  Class II

  FDA 510(k) K121017 Active Cleared 13 Jul 2012

• Spacelabs Healthcare Telemetry Receiver Open recall

  Class II

  FDA 510(k) K141156 Active Cleared 9 Sep 2014

• BLEASE700/900 Series Ventilators

  Class II

  FDA 510(k) K112729 Active Cleared 11 Jun 2012

See all devices from Spacelabs Healthcare Inc. →