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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Carbon-Dioxide, Cutaneous
510(k) Number K043003
Device Name TCM40 MONITORING SYSTEM
Applicant
Radiometer Medical Aps
Akandevej 21 Dk-2700
Bronshoj,  DK
Applicant Contact PIERRE PELLETIER
Correspondent
Radiometer Medical Aps
Akandevej 21 Dk-2700
Bronshoj,  DK
Correspondent Contact PIERRE PELLETIER
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Codes
DQA   KLK   LPP  
Date Received11/01/2004
Decision Date 03/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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