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510(k) Data Aggregation
K Number
K121374Device Name
ZI BLOWER
Manufacturer
Date Cleared
2013-02-22
(291 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
DESHUM MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ZI blower is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with obstructive sleep apnea.
Device Description
The Z1 Blower provides the patient with a continuous positive airway pressure (CPAP) flow ranging from 4-20 cmH2O above ambient atmospheric pressure. The device consists of a flow generator and data interfaces. It is intended for home use, and for prescription use only. Treatment settings (e.g., air pressure, ramp) are directed by the physician and can be modified by the physician.
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