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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
510(k) Number K001866
Device Name TCM400
Applicant
Radiometer Medical A/S
Akandevej 21 Dk-2700
Bronshoj,  DK
Applicant Contact KRISTEN RONO
Correspondent
Radiometer Medical A/S
Akandevej 21 Dk-2700
Bronshoj,  DK
Correspondent Contact KRISTEN RONO
Regulation Number868.2500
Classification Product Code
LPP  
Date Received06/20/2000
Decision Date 12/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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