BLEASE700/900 Series Ventilators

• • Terminated Z-1458-2015 FDA Class II ·initiated 5 Mar 2015

  Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume (Vte) measurements from the pediatric flow sensor are reporting out of specification low compared to the actual delivered volumes being administered to the patient.

510(k) Number

K112729 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

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

• Speacelabs Multigas Module

  Class II

  FDA 510(k) K112173 Active Cleared 5 Oct 2011

• 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

See all devices from Spacelabs Healthcare Inc. →