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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K072014
Device Name VITASCORE
Applicant
VITASCORE B.V.
KROMSTRAAT 3
GEMERT,  NL NL 5421 XZ
Applicant Contact WIM MARTENS
Correspondent
VITASCORE B.V.
KROMSTRAAT 3
GEMERT,  NL NL 5421 XZ
Correspondent Contact WIM MARTENS
Regulation Number868.2375
Classification Product Code
MNR  
Date Received07/23/2007
Decision Date 11/08/2007
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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