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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
Recalls CDRH Recalls
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