Device (90478 +2 more) - 90479 Telemetry Rec. Module

• • 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

• Spacelabs Medical Model 90481 EEG Module

  Class II

  FDA 510(k) K932842 Active Cleared 2 Mar 1994

• Spacelabs Medical ECG Module (Model 90492)

  Class II

  FDA 510(k) K942058 Active Cleared 17 May 1995

• Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories Model-91842

  Class II

  FDA 510(k) K060900 Active Cleared 23 Jun 2006

• Spacelabs Medical Full Disclosure System, Model 91810

  Class II

  FDA 510(k) K063490 Active Cleared 15 Mar 2007

• Spacelabs Healthcare Qube Compact Monitor (91390 Open recall

  Class II

  FDA 510(k) K120616 Active Cleared 29 Mar 2012

• Spacelabs Medical Patient Monitors

  Class II

  FDA 510(k) K102422 Active Cleared 7 Dec 2010

See all devices from Spacelabs Medical, Inc. →