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510(k) K093154

TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM by Radiometer Medical Aps — Product Code LKD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2010
Date Received
October 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Carbon-Dioxide, Cutaneous
Device Class
Class II
Regulation Number
868.2480
Review Panel
AN
Submission Type

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