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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Pressure
510(k) Number K081823
Device Name MASTERSCREEN PAED - BABY BODY
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 Number868.1750
Classification Product Code
CCM  
Subsequent Product Code
BZC  
Date Received06/27/2008
Decision Date 05/18/2009
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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