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510(k) K052244

IISIS, VERSION 1.0 by Innovision Medical Technologies, LLC — Product Code MOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2005
Date Received
August 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory To Continuous Ventilator (Respirator)
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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