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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 K031515
Device Name SPIROPRO SPO2
Applicant
Viasys Healthcare GmbH
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact EARL DRAPER
Correspondent
Viasys Healthcare GmbH
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact EARL DRAPER
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
BTY  
Date Received05/14/2003
Decision Date 11/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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