Surface Skin Temp Probe W/Thermocouple Type T

• 2 recalls, same reason

  • Terminated Z-0768-06 FDA Unclassified (pre-2012) ·initiated 8 Mar 2006
  • Terminated Z-0767-06 FDA Unclassified (pre-2012) ·initiated 8 Mar 2006

  Product temperature readings may be 2C higher than the actual temperature

510(k) Number

K864195 ↗

FDA Product Code

FLL

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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