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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 K041724
Device Name COMPASS M10 SYSTEM
Applicant
MEDCARE FLAGA
SIDUMULI 24
REYKJAVIK,  IS 108
Applicant Contact BERGLIND HALLGRIMSDOTTIR
Correspondent
MEDCARE FLAGA
SIDUMULI 24
REYKJAVIK,  IS 108
Correspondent Contact BERGLIND HALLGRIMSDOTTIR
Regulation Number868.2375
Classification Product Code
MNR  
Date Received06/24/2004
Decision Date 09/28/2004
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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