E100 Series SPO2 Sensors

• • Terminated Z-1188-2008 FDA Unclassified (pre-2012) ·initiated 18 May 2007

  Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those Ohmeda Tuffsat monitors previously re-configured by Ohmeda to include a detection circuit for diodes.

510(k) Number

K970098 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• SPO2 Wrap Sensor

  Class II

  FDA 510(k) K992211 Active Cleared 22 Dec 1999

• Epic SPO2 Finger Sensor, Model E412-20

  Class II

  FDA 510(k) K002223 Active Cleared 22 Aug 2000

• Stat-Shell Disposable SPO2 Sensor

  Class II

  FDA 510(k) K992092 Active Cleared 22 Dec 1999

• E100A Pulse Oximeter Finger Sensor/Probe

  Class II

  FDA 510(k) K954168 Active Cleared 12 Sep 1996

• Transducers for Ultrasound and Tocodynamometer Fetal Monitoring

  Class II

  FDA 510(k) K992811 Active Cleared 18 Jan 2000

• Flexi-Site (E203-01)/ Flexi-Fit (E300)

  Class II

  FDA 510(k) K964055 Active Cleared 21 Feb 1997

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