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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K101619
Device Name WELCH ALLYN 1500 PATIENT MONITOR
Applicant
Schiller AG
Altgasse 68
Baar,  CH 6341
Applicant Contact SERKAN SEZER
Correspondent
Schiller AG
Altgasse 68
Baar,  CH 6341
Correspondent Contact SERKAN SEZER
Regulation Number870.1025
Classification Product Code
MHX  
Date Received06/09/2010
Decision Date 11/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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