Braemar ER900 Wireless Series Arrhythmia Event Recorder

• • Terminated Z-1652-2013 FDA Class II ·initiated 24 Feb 2012

  Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact.

• • Terminated Z-1645-2013 FDA Class II ·initiated 2 May 2011

  Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result in any patient related injury or present any clinical impact.

510(k) Number

K072008 ↗

FDA Product Code

DRG

Device Class

Class II

Regulation

21 CFR Part 870.2910

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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