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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 doppler, ultrasonic
510(k) Number K111582
Device Name LOGIQ S8
Original Applicant
GE HEALTHCARE
9900 innovation drive
mail stop rp-2138
wauwatosa,  WI  53226
Original Contact bryan behn
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/06/2011
Decision Date 07/26/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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