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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 K844682
Device Name ELECATH CARDIAC OUTPUT COMPUTER
Applicant
Electro-Catheter Corp.
2100 Felver Ct.
P.O. Box 1214c
Rahway,  NJ  07065
Applicant Contact SILPE
Correspondent
Electro-Catheter Corp.
2100 Felver Ct.
P.O. Box 1214c
Rahway,  NJ  07065
Correspondent Contact SILPE
Regulation Number870.1435
Classification Product Code
DXG  
Date Received11/30/1984
Decision Date 03/06/1985
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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