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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
  1.  K223246  Hillrom Heart and Respiration Rate Monitoring Syst ...
CIRCADIA TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
EARLYSENSE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
FACEHEART CORP.
  SUBSTANTIALLY EQUIVALENT 1
HEROIC FAITH INTERNATIONAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTELLIGENT DOTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
LINSHOM MANAGEMENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
LINSHOM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAKANI SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MASIMO CORPORATION
  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
SHENZHEN FIBER MEDICAL TECHNOLOGY CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOUND LIFE SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TURTLE SHELL TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 10 10
2019 13 13
2020 10 10
2021 1 1
2022 2 2
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 2 2
Insufficient Device Problem Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 20 20
No Clinical Signs, Symptoms or Conditions 6 6
Death 5 5
No Patient Involvement 4 4
Loss of consciousness 1 1
Tachycardia 1 1
Cardiopulmonary Arrest 1 1

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