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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 K092324
Device Name SPIROPRO
Applicant
VIASYS HEALTHCARE GMBH
LEIBNIZSTRASSE 7
HOECHBERG,  DE 97204
Applicant Contact THOMAS RUST
Correspondent
VIASYS HEALTHCARE GMBH
LEIBNIZSTRASSE 7
HOECHBERG,  DE 97204
Correspondent Contact THOMAS RUST
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
BTY  
Date Received08/04/2009
Decision Date 09/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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