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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Volume
510(k) Number K072061
Device Name MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
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 Number868.1760
Classification Product Code
JEH  
Date Received07/27/2007
Decision Date 04/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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