Bci 6004 Nibp Monitor with Nellcor Pulse Oximeter

• • Terminated Z-1649-2008 FDA Unclassified (pre-2012) ·initiated 2 Apr 2008 ·on shared 510(k) K031742

  Due to a component that may be installed backwards, the device may turn off or may immediately reset.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K031742 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Bci 3178 Pediatric Pulse Oximetry Sensor

  Class II

  FDA 510(k) K020739 Active Cleared 3 Jun 2002

• Bci 3180 Pulse Oximeter

  Class II

  FDA 510(k) K020350 Active Cleared 30 Apr 2002

• Irrigator, Body Cavity

  Class II

  FDA 510(k) K781918 Active Cleared 15 Feb 1979

• 3420 Digit Pulse Oximeter, Model 3420

  Class II

  FDA 510(k) K013171 Active Cleared 3 Jan 2002

• Capnocheck Open recall

  Class II

  FDA 510(k) K941982 Active Cleared 17 Oct 1994

• Sharps Container 18 Gallon

  Class II

  FDA 510(k) K944121 Active Cleared 27 Jan 1995

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