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510(k) Data Aggregation
K Number
K200698Device Name
Somnera System
Manufacturer
Date Cleared
2020-06-29
(104 days)
Product Code
Regulation Number
868.5273Why did this record match?
Applicant Name (Manufacturer) :
FRESCA Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Somnera System is intended to treat Obstructive Sleep Apnea by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and during an incipient apnea. The system includes a dedicated flow generator and a patient interface; and is intended for use in the home environment. The system is to be used by adult patients weighing more than 66 lbs. (30 kg.).
Device Description
The Somnera System is a positive airway pressure system comprised of an airflow generator and a patient interface. The patient interface has a SmartValve™ seated in either a nasal mask or nasal pillow mask. A hose connects the valve to the generator. The mask is held in place with adjustable headgear straps. The patient interface is supplied non-sterile and intended for single patient reuse in the home environment. The Somnera System is a prescription device.
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