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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
Recalls CDRH Recalls
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