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510(k) Data Aggregation
K Number
K150685Device Name
Skynector CPAP Mask
Date Cleared
2015-08-24
(160 days)
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.
The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed.
The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital /institutional environment.
Device Description
The Skynector CPAP masks are designed based on human facial shape and structure, and the operating characteristics during application, they are injection mold of hard PC plastic and soft silicone rubber materials, with high level of air tightness, convenient operation and comfortable to wear, etc. They are used for the interfacing devices that are used to provide users with Continuous Positive Airway Pressure (CPAP) ventilation or biphasic positive airway pressure (BiPAP) ventilation treatment.
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