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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 K062011
Device Name MODIFICATION TO FLOWSCREEN
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 Number868.1890
Classification Product Code
BTY  
Date Received07/17/2006
Decision Date 05/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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