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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilatory effort recorder
Product CodeMNR
Regulation Number 868.2375
Device Class 2


Premarket Reviews
ManufacturerDecision
ACURABLE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
BELUN TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BRESOTEC INC
  SUBSTANTIALLY EQUIVALENT 1
COMPUMEDICS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DYMEDIX DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ECTOSENSE NV
  SUBSTANTIALLY EQUIVALENT 3
EMBLA SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ENSODATA
  SUBSTANTIALLY EQUIVALENT 1
ITAMAR MEDICAL, LTD
  SUBSTANTIALLY EQUIVALENT 2
ITAMAR MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2
MYCARDIO, LLC DBA SLEEPIMAGE.
  SUBSTANTIALLY EQUIVALENT 1
NEUROVIRTUAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
ONERA B.V.
  SUBSTANTIALLY EQUIVALENT 2
RESAPP HEALTH
  SUBSTANTIALLY EQUIVALENT 1
RESONEA, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIBEL INC.
  SUBSTANTIALLY EQUIVALENT 1
WESPER INC.
  SUBSTANTIALLY EQUIVALENT 2
ZEPHYR SLEEP TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 3 3
2020 5 5
2021 5 5
2022 4 4
2023 13 13
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6 6
Battery Problem 3 3
Overheating of Device 3 3
Failure to Power Up 2 2
Electrical /Electronic Property Problem 2 2
Smoking 2 2
Excessive Heating 2 2
Lack of Effect 1 1
Electrical Shorting 1 1
Flare or Flash 1 1
Power Problem 1 1
Temperature Problem 1 1
Patient Device Interaction Problem 1 1
Unintended Electrical Shock 1 1
Use of Device Problem 1 1
Device Displays Incorrect Message 1 1
Accessory Incompatible 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
Blister 5 5
Discomfort 4 4
Sleep Dysfunction 3 3
Superficial (First Degree) Burn 3 3
Pain 3 3
Burn(s) 3 3
Burning Sensation 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
Partial thickness (Second Degree) Burn 1 1
Shock from Patient Lead(s) 1 1
Malaise 1 1
Increased Sensitivity 1 1
Skin Inflammation/ Irritation 1 1
Apnea 1 1
Erythema 1 1
Rash 1 1
Skin Irritation 1 1
Tachycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 NOX MEDICAL II Oct-05-2021
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