Harmone-Schwarzer EEG System

• • Terminated Z-1080-2013 FDA Class II ·initiated 6 Apr 2009 ·on shared 510(k) K010728

  The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K010728 ↗

FDA Product Code

OLV

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Luna

  Class II

  FDA 510(k) K982351 Active Cleared 29 Jul 1998

• Rhythm

  Class I

  FDA 510(k) K912938 Active Cleared 30 Jul 1991

• Eclipse Version 3.0

  Class II

  FDA 510(k) K955577 Active Cleared 20 Sep 1996

• Notta Ambulatory Recorder

  Class II

  FDA 510(k) K013450 Active Cleared 14 Jan 2002

• Harmonie System

  Class II

  FDA 510(k) K083577 Active Cleared 29 Aug 2011

• Harmonie Sensa

  Class II

  FDA 510(k) K960273 Active Cleared 4 Apr 1996