Model 90478 & 90479 Telemetry Rec. Module&Housing

• • Terminated Z-1652-2008 FDA Unclassified (pre-2012) ·initiated 18 Jul 2008

  Telemetry Modules are failing to alarm for low heart rate and asystole.

• • Terminated Z-1202-06 FDA Unclassified (pre-2012) ·initiated 5 May 2006

  Potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.

510(k) Number

K925510 ↗

FDA Product Code

DSI

Models / Variants

90478

90479 Telemetry Rec. Module

Housing

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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