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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K911761
Device Name SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION
Applicant
S & W MEDICO TEKNIK
HERSTEDVANG 8
DK-2620 ALBERTSLUND
DENMARK,  DK
Applicant Contact LISBETH ISBRANDT
Correspondent
S & W MEDICO TEKNIK
HERSTEDVANG 8
DK-2620 ALBERTSLUND
DENMARK,  DK
Correspondent Contact LISBETH ISBRANDT
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/22/1991
Decision Date 10/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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