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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, Diagnostic
510(k) Number K001016
Device Name GE LOGIQ 700
Applicant
GE Medical Systems
P.O.Box 414
Milwaukee,  WI  53188
Applicant Contact ALLEN SCHUH
Correspondent
GE Medical Systems
P.O.Box 414
Milwaukee,  WI  53188
Correspondent Contact ALLEN SCHUH
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO  
Date Received03/29/2000
Decision Date 04/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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