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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 K991446
Device Name BIOSACA SYSTEM, MODEL 800
Applicant
BIOSYS AB (PUBL)
485 LAROE RD.
CHESTER,  NY  10918
Applicant Contact JANE B CAMPBELL
Correspondent
BIOSYS AB (PUBL)
485 LAROE RD.
CHESTER,  NY  10918
Correspondent Contact JANE B CAMPBELL
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received04/26/1999
Decision Date 07/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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