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510(k) K043003

TCM40 MONITORING SYSTEM by Radiometer Medical Aps — Product Code LKD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2005
Date Received
November 1, 2004
Clearance Type
Abbreviated
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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