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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 DK-2700
Applicant Contact KRISTEN RONO
Correspondent
RADIOMETER MEDICAL A/S
AKANDEVEJ 21
DK-2700 BRONSHOJ,  DK DK-2700
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
Recalls CDRH Recalls
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