Npb-295 Pulse Oximeter

• • Terminated Z-0663-05 FDA Unclassified (pre-2012) ·initiated 18 Oct 2004

  The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.

510(k) Number

K973147 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Shiley Flextra Tracheostomy Tube

  Class II

  FDA 510(k) K030787 Active Cleared 14 Nov 2003

• Nellcor Symphony N-3000 Patient Monitor with SPO2 and ECG and N-3200 Display/Printer

  Class II

  FDA 510(k) K963400 Active Cleared 26 Nov 1996

• Npb-290 Pulse Oximeter (Npb-290)

  Class II

  FDA 510(k) K972837 Active Cleared 21 Oct 1997

• Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-Al, Max-N, Max-I, Max-P

  Class II

  FDA 510(k) K052186 Active Cleared 10 Nov 2005

• Nellcor Puritan Bennett Achieva Ventilator and Report Generator

  Class II

  FDA 510(k) K990177 Active Cleared 18 Nov 1999

• Nellcor N-200 Pulse Oximeter, Model N-200

  Class II

  FDA 510(k) K022819 Active Cleared 24 Sep 2002

See all devices from Nellcor Puritan Bennett, Inc. →