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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Product CodeGKJ
Regulation Number 864.5850
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2018 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Smoking 1 1
Sparking 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1

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