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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K991842
Device Name SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING
Applicant
Ge Vingmed Ultrasound
P.O. Box 141
Horten,  NO N-3191
Applicant Contact PAUL FREDRIKSEN
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact CHANTEL CARSON
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received05/28/1999
Decision Date 06/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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