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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
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