Pedi-Cap

• • Terminated Z-2047-2009 FDA Unclassified (pre-2012) ·initiated 14 Aug 2009

  CO2 detector may increase resistance to air flow in an intubated patient.

510(k) Number

K944400 ↗

FDA Product Code

CCK

Device Class

Class II

Regulation

21 CFR Part 868.1400

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Nellcor Symphony(Tm) N-3100 Blood Pressure Monitor and Connected to the Nellcor Symphony(Tm) N-3000 Pulse Oximeter

  Class II

  FDA 510(k) K945947 Active Cleared 8 Mar 1995

• Nellcor Portable Pulse Oximeter Model N-20

  Class II

  FDA 510(k) K915699 Active Cleared 27 May 1993

• Nellcor(R) N-180 Pulse Oximeter

  Class II

  FDA 510(k) K913695 Active Cleared 13 Nov 1991

• Nellcor Symphony N-3000 Pulse Oximeter

  Class II

  FDA 510(k) K952316 Active Cleared 17 Aug 1995

• Nellcor Symphony N-3100 Blood Pressure Monitor

  Class II

  FDA 510(k) K953472 Active Cleared 20 Oct 1995

• Nellcor Stat-Cap Airway CO2 Indicator, Model N-60

  Class II

  FDA 510(k) K915494 Active Cleared 6 Aug 1993

See all devices from Nellcor, Inc. →