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510(k) K160127

iCodeConnect by 3B Medical, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2016
Date Received
January 20, 2016
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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