Elance Vital Signs Monitor and Elance Central Station

• • Terminated Z-2916-2011 FDA Unclassified (pre-2012) ·initiated 6 Jul 2011

  Model 93300 Vital Signs Monitor may stop operating while in use, and when this occurs, the monitor may also fail to power ON. The resulting situation may cause a loss of monitoring for the patient.

• • Terminated Z-3024-2011 FDA Unclassified (pre-2012) ·initiated 23 Sep 2010

  The monitor has a 3 second delay in the waveforms and respiration alarm; the delay is not disclosed in the IFU.

510(k) Number

K093501 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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