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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K883889
Device Name TRANSESOPHAGEAL ECHO TRANSDUCER
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact KROGER, PHD
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact KROGER, PHD
Regulation Number870.2880
Classification Product Code
JOP  
Date Received09/14/1988
Decision Date 11/29/1988
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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