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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K010770
Device Name BCI ADVISOR VITAL SIGNS MONITOR (9200)
Applicant
BCI, INC.
N7 W22025 JOHNSON RD.
WAUKESHA,  WI  53186
Applicant Contact DONALD ALEXANDER
Correspondent
BCI, INC.
N7 W22025 JOHNSON RD.
WAUKESHA,  WI  53186
Correspondent Contact DONALD ALEXANDER
Regulation Number870.2300
Classification Product Code
MWI  
Date Received03/14/2001
Decision Date 06/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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