MARSPO2, Model 2001

• • Terminated Z-1049-04 FDA Unclassified (pre-2012) ·initiated 2 Sep 2002

  Audio alarm may fail to sound when SpO2 limits drop below the set limits

510(k) Number

K993979 ↗

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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