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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, pulmonary function data
510(k) Number K040698
Device Name MASTERSCREEN CPX AND OXYCON CPX
Applicant
VIASYS HEALTHCARE GMBH
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Applicant Contact EDMOND CHU
Correspondent
VIASYS HEALTHCARE GMBH
22705 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Correspondent Contact EDMOND CHU
Regulation Number868.1880
Classification Product Code
BZC  
Date Received03/17/2004
Decision Date 04/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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