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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 K982279
Device Name VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200
Applicant
Bci Intl., Inc.
W238 N1650 Rockwood Dr.
Waukesha,  WI  53188
Applicant Contact DONALD J ALEXANDER
Correspondent
Bci Intl., Inc.
W238 N1650 Rockwood Dr.
Waukesha,  WI  53188
Correspondent Contact DONALD J ALEXANDER
Regulation Number870.1025
Classification Product Code
MHX  
Date Received06/30/1998
Decision Date 09/25/1998
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
Recalls CDRH Recalls
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