Model 90421 Flexport Interface

• • Terminated Z-1824-2014 FDA Class II ·initiated 9 May 2014

  Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.

510(k) Number

K903702 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Heartrate Plus ECG Cardule #1918

  Class II

  FDA 510(k) K830306 Active Cleared 17 Mar 1983

• Spacelabs Series 1000

  Class II

  FDA 510(k) K760612 Active Cleared 21 Sep 1976

• Spacelabs Series 90700 Patient Monitors

  Class II

  FDA 510(k) K862951 Active Cleared 23 Sep 1986

• Spacelabs-General System Link

  Class II

  FDA 510(k) K850627 Active Cleared 28 May 1985

• Spacelabs Arrhythmia Net (Tm) Level 2

  Class II

  FDA 510(k) K864505 Active Cleared 24 Nov 1986

• Space Labs Model 90560

  Not classified

  FDA 510(k) K923788 Active Cleared 6 Dec 1993

See all devices from Spacelabs, Inc. →