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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, nerve conduction velocity measurement
Regulation Description Nerve conduction velocity measurement device.
Product CodeJXE
Regulation Number 882.1550
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
EXCEL TECH. LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSIGHT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. III May-10-2012

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