Autocorr Plus; 3404 Oximeter/ECG Monitor

• • Terminated Z-1240-2007 FDA Unclassified (pre-2012) ·initiated 18 Jul 2007

  Phantom pacer spikes caused by a damaged resistor.

• • Terminated Z-0300-2007 FDA Unclassified (pre-2012) ·initiated 6 Nov 2006

  An error occurred at the board manufacturing site which may affect the following parameters: - An electrical noise observed on the SpO2 pleth waveform generating and displaying erratic heart rates. % SpO2 reading displays dashes. - The ECG waveform may appear noisy, ECG readings appear accurate. -Respiration waveform may appear noisy and the respiration readings will be displayed as dashes.

510(k) Number

K981939 ↗

FDA Product Code

DQA

Models / Variants

Autocorr Plus

3404 Oximeter/Ecg Monitor

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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