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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 K941289
Device Name PULSE OXIMETER
Applicant
Bci Intl., Inc.
W238 N1650 Rockwood Dr.
Waukesha,  WI  53188
Applicant Contact SCOTT J PEASE
Correspondent
Bci Intl., Inc.
W238 N1650 Rockwood Dr.
Waukesha,  WI  53188
Correspondent Contact SCOTT J PEASE
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/17/1994
Decision Date 06/22/1994
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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