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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 K983550
Device Name XYZ SYSTEM
Applicant
BIO-MONITORING INTERNATIONAL CORP.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact ANAND AKERKAR
Correspondent
BIO-MONITORING INTERNATIONAL CORP.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact ANAND AKERKAR
Regulation Number882.5050
Classification Product Code
HCC  
Date Received10/09/1998
Decision Date 01/07/1999
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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