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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, breathing frequency
Regulation Description Breathing frequency monitor.
Product CodeBZQ
Regulation Number 868.2375
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPRORATION
  SUBSTANTIALLY EQUIVALENT 1
FACEHEART CORP.
  SUBSTANTIALLY EQUIVALENT 1
HEROIC FAITH INTERNATIONAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
LINSHOM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAKANI SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PMD SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
RESPIREE PTE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
RTM VITAL SIGNS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SOUND LIFE SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TURTLE SHELL TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 2 2
Insufficient Information 1 1
Wireless Communication Problem 1 1
Device Fell 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Application Network Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4

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