Reflectance Sensor (Rs-10)

• • Terminated Z-1125-2017 FDA Class II ·initiated 16 Dec 2016

  Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.

510(k) Number

K904039 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Nellcor, Inc. →