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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 K012226
Device Name MONITORING SYSTEM,MODEL ARGUS PB-1000
Applicant
Schiller AG
Altgasse 68
Baar,  CH CH-6341
Applicant Contact MARKUS BUETLER
Correspondent
Schiller AG
Altgasse 68
Baar,  CH CH-6341
Correspondent Contact MARKUS BUETLER
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/16/2001
Decision Date 04/08/2002
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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