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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 K913013
Device Name TCPO2 9260 MODULE - SYSTEM ATHENA
Applicant
S & W Medico Teknik
Herstedvang 8
Dk-2620 Albertslund
Denmark,  DK
Applicant Contact MORTEN NIELSON
Correspondent
S & W Medico Teknik
Herstedvang 8
Dk-2620 Albertslund
Denmark,  DK
Correspondent Contact MORTEN NIELSON
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Code
KLK  
Date Received07/08/1991
Decision Date 05/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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