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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device oximeter, tissue saturation, reprocessed
Definition Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNMD
Regulation Number 870.2700
Device Class 2

MDR Year MDR Reports MDR Events
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Communication or Transmission Problem 2 2
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

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