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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 K083557
Device Name BCI WW1030 PULSE OXIMETER
Applicant
SMITHS MEDICAL PM, INC.
N7 W22025 JOHNSON DR.
WAUKESHA,  WI  53186 -1856
Applicant Contact DONALD ALEXANDER
Correspondent
SMITHS MEDICAL PM, INC.
N7 W22025 JOHNSON DR.
WAUKESHA,  WI  53186 -1856
Correspondent Contact DONALD ALEXANDER
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/02/2008
Decision Date 05/01/2009
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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