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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, oxygen, cutaneous, for infant not under gas anesthesia
Regulation Description Cutaneous oxygen (PcO2) monitor.
Product CodeKLK
Regulation Number 868.2500
Device Class 2

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cyanosis 1 1
Diminished Pulse Pressure 1 1
Unspecified Tissue Injury 1 1
Unspecified Respiratory Problem 1 1

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