Spacelabs Medical Full Disclosure System, Model 91810

• • Terminated Z-2270-2010 FDA Unclassified (pre-2012) ·initiated 17 Oct 2008

  Potential for device to print out the wrong waveform data for the time indicated in the printout or display.

510(k) Number

K063490 ↗

FDA Product Code

DQK

Device Class

Class II

Regulation

21 CFR Part 870.1425

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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