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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device computer, oxygen-uptake
Product CodeBZL
Regulation Number 868.1730
Device Class 2


Premarket Reviews
ManufacturerDecision
COSMED NORDIC APS
  SUBSTANTIALLY EQUIVALENT 1
TF HEALTH CO.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K200076  Breezing Med

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cycle 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

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