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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K011177
Device Name BCI ADVISOR VITAL SIGNS MONITOR (9200)
Applicant
BCI, INC.
N7 W22025 JOHNSON RD.
WAUKESHA,  WI  53186
Applicant Contact DONALD J ALEXANDER
Correspondent
BCI, INC.
N7 W22025 JOHNSON RD.
WAUKESHA,  WI  53186
Correspondent Contact DONALD J ALEXANDER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received04/17/2001
Decision Date 05/23/2001
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
Recalls CDRH Recalls
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