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510(k) Data Aggregation
K Number
K140929Device Name
Z1 CPAP SYSTEM
Manufacturer
Date Cleared
2014-10-17
(191 days)
Product Code
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
HUMAN DESIGN MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Z1 CPAP System is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults weighing over 66 lbs (30 kg) with obstructive sleep apnea.
Device Description
The Z1 CPAP System provides continuous positive pressure to support the treatment of adults over 66 lbs (30 kg) with obstructive sleep apnea. The device is a non-critical care, reusable, single patient device for use in the home setting, and it is intended to be a prescription use only device. The Z1 CPAP System is a modified version of the Z1 Blower cleared in K121374. The modifications include: addition of an optional battery, addition of an APAP mode, addition of Bluetooth and a mobile app, addition of new user settings, and changes to firmware.
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