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510(k) K152068

Astral 100/150 by Resmed, Ltd. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2016
Date Received
July 24, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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