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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K915633
Device Name MOD. TYPE 9230 TEMP 1 AND TEMP 2 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 Number880.2910
Classification Product Code
FLL  
Date Received10/29/1991
Decision Date 06/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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