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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
BRONSHOJ,  DK DK-2700
Applicant Contact PIERRE PELLETIER
Correspondent
RADIOMETER MEDICAL APS
AKANDEVEJ 21
BRONSHOJ,  DK DK-2700
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
Recalls CDRH Recalls
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