Nellcor Puritan Bennett Gemini

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K972248 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

ST

• 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. →