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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Sleep Assessment
510(k) Number K912817
Device Name SOMNIMIC (R)
Applicant
Somnitec, Inc.
C/O Dawn Medical
210 San Benito Way
San Francisco,  CA  94127
Applicant Contact BRUCE FITZGERALD
Correspondent
Somnitec, Inc.
C/O Dawn Medical
210 San Benito Way
San Francisco,  CA  94127
Correspondent Contact BRUCE FITZGERALD
Regulation Number882.5050
Classification Product Code
LEL  
Date Received05/21/1991
Decision Date 07/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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