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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 K060708
Device Name SOMNOSCREEN
Applicant
SOMNOMEDICS GMBH & CO. KG
719 A STREET NE
WASHINGTON,  DC  20002
Applicant Contact CHERITA JAMES
Correspondent
SOMNOMEDICS GMBH & CO. KG
719 A STREET NE
WASHINGTON,  DC  20002
Correspondent Contact CHERITA JAMES
Regulation Number868.2375
Classification Product Code
MNR  
Date Received03/16/2006
Decision Date 01/24/2007
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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