Oxyshuttle II, Modification

• • Terminated Z-0013-04 FDA Unclassified (pre-2012) ·initiated 16 Nov 2000 ·on shared 510(k) K925542

  Instructions for use contained incorrect sensor reference.

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

510(k) Number

K925542 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Infant Flow Ncpap Masks

  Class II

  FDA 510(k) K984254 Active Cleared 24 Feb 1999

• Sensormedics Model 2130 Spieometry System

  Class II

  FDA 510(k) K920111 Active Cleared 26 Oct 1992

• Sensormedics Model 922 Spirometer

  Class II

  FDA 510(k) K920246 Active Cleared 8 Apr 1992

• Modification to Hiox

  Class II

  FDA 510(k) K030943 Active Cleared 22 Apr 2003

• Sensormedics Model 2450 Pulmonary Function Lab.

  Class II

  FDA 510(k) K915848 Active Cleared 28 Oct 1992

• Pegasus Nasal Cpap System

  Class II

  FDA 510(k) K022192 Active Cleared 24 Jan 2003

See all devices from Sensor Medics Corp. →