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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 K923418
Device Name 9293/1 INTERFACE MODULE
Applicant
S & W Medico Teknik
Herstedvang 8
Dk-2620 Albertslund
Denmark,  DK
Applicant Contact JOSEPH O'GARA
Correspondent
S & W Medico Teknik
Herstedvang 8
Dk-2620 Albertslund
Denmark,  DK
Correspondent Contact JOSEPH O'GARA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/13/1992
Decision Date 02/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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