Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories)

• • Terminated Z-0664-05 FDA Unclassified (pre-2012) ·initiated 18 Oct 2004

  The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.

510(k) Number

K012891 ↗

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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