Bird Avea Ventilator

• 5 recalls, same reason

  • Terminated Z-0983-2008 FDA Unclassified (pre-2012) ·initiated 17 Dec 2007
  • Terminated Z-0985-2008 FDA Unclassified (pre-2012) ·initiated 17 Dec 2007
  • Terminated Z-0982-2008 FDA Unclassified (pre-2012) ·initiated 17 Dec 2007
  • Terminated Z-0986-2008 FDA Unclassified (pre-2012) ·initiated 17 Dec 2007
  • Terminated Z-0984-2008 FDA Unclassified (pre-2012) ·initiated 17 Dec 2007

  Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.

510(k) Number

K022674 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Bird 1000 Pv Portable Ventilator

  Class II

  FDA 510(k) K925422 Active Cleared 13 May 1993

• 6400ST Interface MODULE-RS232

  Class II

  FDA 510(k) K880721 Active Cleared 14 Apr 1988

• Avea

  Class II

  FDA 510(k) K013642 Active Cleared 22 May 2002

• Bird Avian Port Military Vent Nsn 6530-01-374-8903

  Class II

  FDA 510(k) K933262 Active Cleared 29 Jul 1993

• Bird Microblender M.R.I.

  Class II

  FDA 510(k) K895695 Active Cleared 6 Jul 1990

• Bird 6500 Air Compressor

  Class II

  FDA 510(k) K864547 Active Cleared 12 Jan 1987

See all devices from Bird Products Corp. →