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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name standard polysomnograph with electroencephalograph
510(k) Number K003175
Device Name COMPUMEDICS SIESTA SYSTEM
Applicant
COMPUMEDICS LIMITED
6740 RIVERVIEW TERRACE
MINNEAPOLIS,,  MN  55432
Applicant Contact CONSTANCE BUNDY
Correspondent
COMPUMEDICS LIMITED
6740 RIVERVIEW TERRACE
MINNEAPOLIS,,  MN  55432
Correspondent Contact CONSTANCE BUNDY
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received10/10/2000
Decision Date 12/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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