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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K970801
Device Name BCI MODEL 6004 NIBP MONITOR (6004)
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 Number870.1130
Classification Product Code
DXN  
Date Received03/04/1997
Decision Date 11/12/1997
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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