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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 K214039
Device Name LOGIQ P10, LOGIQ P9, LOGIQ P8
Applicant
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Llc
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Bryan Behn
Correspondent
Ge Medical Systems Ultrasound and Primary Care Diagnostics
Llc
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Bryan Behn
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/23/2021
Decision Date 03/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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