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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 K984580
Device Name BIOSACA SYSTEM
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 Codes
DQA   GWQ   MNR  
Date Received12/23/1998
Decision Date 03/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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