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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 K984618
Device Name BCI MINI-TORR PLUS, MODEL 6004
Applicant
Bci Intl., Inc.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Applicant Contact DONALD ALEXANDER
Correspondent
Bci Intl., Inc.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Correspondent Contact DONALD ALEXANDER
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/29/1998
Decision Date 03/25/1999
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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