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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter, wellness
Definition Pulse oximeter intended for wellness use.
Product CodePGJ
Regulation Number 870.2700
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
Unspecified Respiratory Problem 1 1

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