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510(k) K112220

DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL by Devilbiss Healthcare, LLC — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2011
Date Received
August 2, 2011
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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