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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 K081485
Device Name SOMNOWATCH
Applicant
SOMNOMEDICS GMBH
901 KING STREET
SUITE 200
ALEXANDRIA,  VA  22314
Applicant Contact CHERITA JAMES
Correspondent
SOMNOMEDICS GMBH
901 KING STREET
SUITE 200
ALEXANDRIA,  VA  22314
Correspondent Contact CHERITA JAMES
Regulation Number868.2375
Classification Product Code
MNR  
Date Received05/28/2008
Decision Date 09/18/2008
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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