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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device box, battery, rechargeable
Regulation Description Endoscope and accessories.
Product CodeFCO
Regulation Number 876.1500
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
No Patient Involvement 1 1
Low Blood Pressure/ Hypotension 1 1

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