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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 K950536
Device Name PICIS CHART+
Applicant
Picis
Bosch Y Gimpera 30, Barcelona
08034
Spain,  ES 08034
Applicant Contact L. S MONTEJO
Correspondent
Picis
Bosch Y Gimpera 30, Barcelona
08034
Spain,  ES 08034
Correspondent Contact L. S MONTEJO
Regulation Number870.1025
Classification Product Code
MHX  
Date Received02/07/1995
Decision Date 05/17/1995
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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