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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K884135
Device Name DM100 (DISTAL MONITOR - 100)
Applicant
Bio.Logic, Inc.
N. 4708 Warch
Spokane,  WA  99216
Applicant Contact DAVID M BELIVEAU
Correspondent
Bio.Logic, Inc.
N. 4708 Warch
Spokane,  WA  99216
Correspondent Contact DAVID M BELIVEAU
Regulation Number882.5050
Classification Product Code
HCC  
Date Received09/30/1988
Decision Date 01/17/1989
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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