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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K080734
Device Name FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
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 Number868.1890
Classification Product Code
BTY  
Subsequent Product Code
DPS  
Date Received03/14/2008
Decision Date 06/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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