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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter, infrared, sporting, aviation
Definition Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.
Product CodeOCH
Regulation Number 870.2700
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2021 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Device Displays Incorrect Message 1 1
Device Sensing Problem 1 1
Material Integrity Problem 1 1
Poor Quality Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Patient Involvement 1 1

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