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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device positive airway pressure system
Definition A positive airway pressure delivery system is a prescription noninvasive ventilatory device that delivers expiratory positive airway pressure for patients suffering from obstructive sleep apnea. The system also provides positive airway pressure during incipient apnea. The system may include a dedicated flow generator and a patient interface.
Product CodeQBY
Regulation Number 868.5273
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESCA MEDICAL
  GRANTED 1
FRESCA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Emotional Changes 1 1
Pain 1 1
Anxiety 1 1
Sensitivity of Teeth 1 1
Sleep Dysfunction 1 1
Suicidal Ideation 1 1
Sexual Dysfunction 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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