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510(k) K082657

RTX RESPIRATOR by Medivent Limited — Product Code BYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2008
Date Received
September 12, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Device Class
Class II
Regulation Number
868.5935
Review Panel
AN
Submission Type

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