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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name full-montage standard electroencephalograph
510(k) Number K864928
Device Name BIO-LOG 8+1 AMBULATORY PHYSIOLOGIC RECORDER
Applicant
BIO-SCAN, INC.
1717 s. ervay st.
dallas,  TX  75215
Applicant Contact larry s gantt
Correspondent
BIO-SCAN, INC.
1717 s. ervay st.
dallas,  TX  75215
Correspondent Contact larry s gantt
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received12/16/1986
Decision Date 03/31/1987
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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