Capnocheck Ii, Model 8400

• • Terminated Z-0920-2010 FDA Unclassified (pre-2012) ·initiated 15 Jan 2010

  Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are eq

510(k) Number

K991086 ↗

FDA Product Code

CCK

Device Class

Class II

Regulation

21 CFR Part 868.1400

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• NEWOX2

  Class II

  FDA 510(k) K945754 Active Cleared 17 Jul 1995

• Autocorr Plus; 3404 Oximeter/ECG Monitor

  Class II

  FDA 510(k) K981939 Active Cleared 20 Aug 1998

• Pulse Oximeter

  Class II

  FDA 510(k) K941289 Active Cleared 22 Jun 1994

• 3301T Oxitemp

  Class II

  FDA 510(k) K946185 Active Cleared 17 Mar 1995

• BCI 3401 Handheld Pulse Oximeter

  Class II

  FDA 510(k) K980714 Active Cleared 25 Mar 1998

• 3402 Handheld Pulse Oximeter

  Class II

  FDA 510(k) K991410 Active Cleared 9 Jun 1999

See all devices from Bci Intl., Inc. →