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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K862808
Device Name BIOMA 2000
Applicant
E.B.S., Inc.
660 Rochon
St-Laurent (Quebec)
Canada,  CA H4L 1T4
Applicant Contact SYLVAIN BOUCHER
Correspondent
E.B.S., Inc.
660 Rochon
St-Laurent (Quebec)
Canada,  CA H4L 1T4
Correspondent Contact SYLVAIN BOUCHER
Regulation Number870.1435
Classification Product Code
DXG  
Date Received07/23/1986
Decision Date 02/19/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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