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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K942196
Device Name 3050 DIASCOPE NT PATIENT MONITOR
Applicant
S & W Medico Teknik A/S
Herstedvang 8
Albertslund,  DK DK-2620
Applicant Contact MORTEN NIELSEN
Correspondent
S & W Medico Teknik A/S
Herstedvang 8
Albertslund,  DK DK-2620
Correspondent Contact MORTEN NIELSEN
Regulation Number870.1025
Classification Product Code
DSI  
Date Received05/04/1994
Decision Date 06/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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