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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device apparatus, air handling, room
Product CodeFZH
Regulation Number 878.5070
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2022 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5 5
Device-Device Incompatibility 4 4
Material Deformation 1 1
Insufficient Information 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
Injury 1 1
Pain 1 1
Disability 1 1

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