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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 K082539
Device Name MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
Applicant
CARDINAL HEALTH GERMANY 234 GMBH
LEIBNIZSTRASSE 7
HOECHBERG, BAVARIA,  DE 97204
Applicant Contact THOMAS RUST
Correspondent
CARDINAL HEALTH GERMANY 234 GMBH
LEIBNIZSTRASSE 7
HOECHBERG, BAVARIA,  DE 97204
Correspondent Contact THOMAS RUST
Regulation Number868.1890
Classification Product Code
BTY  
Subsequent Product Code
DPS  
Date Received09/02/2008
Decision Date 12/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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