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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 K072323
Device Name MASTERSCREEN & OXYCON CPX
Applicant
Viasys Healthcare GmbH
22745 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact Yvette Lloyd
Correspondent
Viasys Healthcare GmbH
22745 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact Yvette Lloyd
Regulation Number868.1880
Classification Product Code
BZC  
Date Received08/20/2007
Decision Date 10/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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