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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, communication, powered
Regulation Description Powered communication system.
Product CodeILQ
Regulation Number 890.3710
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 1 0 2 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Lifeline Systems, Incorporated II Oct-01-2015
2 Lifeline Systems, Incorporated II Jul-06-2015
3 Philips Lifeline Inc II Nov-25-2009
4 Rauland-Borg Corp II Sep-17-2013
5 Tobii Assistive Technology, Inc. II Feb-01-2013
6 Tobii Assistive Technology, Inc. II Jun-29-2011

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