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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, temperature discrimination
Product CodeLQW
Regulation Number 882.1200
Device Class 1


Premarket Reviews
ManufacturerDecision
PROSENEX
  SUBSTANTIALLY EQUIVALENT 1

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

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 1 1
Device Sensing Problem 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 1 1
Erythema 1 1
Blister 1 1
Pain 1 1
No Code Available 1 1

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