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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 K011156
Device Name BCI 3403 SLEEP SCREENING PULSE OXIMETER
Applicant
Bci, Inc.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Applicant Contact DONALD ALEXANDER
Correspondent
Bci, Inc.
N7 W22025 Johnson Rd.
Waukesha,  WI  53186
Correspondent Contact DONALD ALEXANDER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/16/2001
Decision Date 06/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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