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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 K870375
Device Name MODEL 617 CARDIAC OUTPUT COMPUTER
Applicant
Omnimed B.V.
C/O Int'L Marketing Consultant
Jan Van Nassaustraat 12
2596 Bt S-Gravenhage,  NL
Applicant Contact JEF HAARMANS
Correspondent
Omnimed B.V.
C/O Int'L Marketing Consultant
Jan Van Nassaustraat 12
2596 Bt S-Gravenhage,  NL
Correspondent Contact JEF HAARMANS
Regulation Number870.1435
Classification Product Code
DXG  
Date Received01/29/1987
Decision Date 06/16/1987
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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