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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K031742
Device Name BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
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 Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DXN  
Date Received06/04/2003
Decision Date 08/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
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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