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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 K980714
Device Name BCI 3401 HANDHELD PULSE OXIMETER
Applicant
BCI INTL., INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53188
Applicant Contact DONALD J ALEXANDER
Correspondent
BCI INTL., INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA,  WI  53188
Correspondent Contact DONALD J ALEXANDER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/24/1998
Decision Date 03/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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