CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor

• • Terminated Z-2232-2009 FDA Unclassified (pre-2012) ·initiated 30 Jun 2009 ·on shared 510(k) K060065

  1) The monitor's ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) The unit generates electromagnetic radiation above the limits set by applicable standards for medical devices

• 2 recalls, same reason

  • Terminated Z-0178-2008 FDA Unclassified (pre-2012) ·initiated 28 Jul 2007
  • Terminated Z-0177-2008 FDA Unclassified (pre-2012) ·initiated 28 Jul 2007

  Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.

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

510(k) Number

K060065 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• CAPNOSTREAM20 With Integrated Pulmonary Index

  Class II

  FDA 510(k) K082268 Active Cleared 6 Feb 2009

• Capnostream 20 with A2 Adaptive Averaging Software

  Class II

  FDA 510(k) K072295 Active Cleared 11 Oct 2007

• CAPNOSTREAM20 with MICROMEDICO2 Module

  Class II

  FDA 510(k) K094012 Active Cleared 12 May 2010

• Capnostream 20P with Masimo SPO2 Board

  Class II

  FDA 510(k) K101995 Active Cleared 11 Jan 2011