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510(k) K140929

Z1 CPAP SYSTEM by Human Design Medical, LLC — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2014
Date Received
April 9, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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