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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K052571
Device Name MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
Applicant
Neurognostics, Inc.
10437 Innovation Dr.
Suite 309
Milwaukee,  WI  53226
Applicant Contact Hrishikesh Gadagkar
Correspondent
Neurognostics, Inc.
10437 Innovation Dr.
Suite 309
Milwaukee,  WI  53226
Correspondent Contact Hrishikesh Gadagkar
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/19/2005
Decision Date 10/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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