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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 K180455
Device Name NeuralBot
Applicant
Neural Analytics, Inc.
2440 S. Sepulveda Blvd., Suite 115
Los Angeles,  CA  90064
Applicant Contact Javad Seyedzadeh
Correspondent
Neural Analytics, Inc.
2440 S. Sepulveda Blvd., Suite 115
Los Angeles,  CA  90064
Correspondent Contact Javad Seyedzadeh
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   OQQ  
Date Received02/20/2018
Decision Date 05/22/2018
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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