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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 K962128
Device Name TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)
Applicant
Hemo Sapiens, Inc.
19211 Edgehill Dr.
Irvine,  CA  92612
Applicant Contact B. BO SRAMEK
Correspondent
Hemo Sapiens, Inc.
19211 Edgehill Dr.
Irvine,  CA  92612
Correspondent Contact B. BO SRAMEK
Regulation Number870.1435
Classification Product Code
DXG  
Date Received06/03/1996
Decision Date 11/21/1996
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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