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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K894097
Device Name NTI-1000
Applicant
Neurotek, Inc.
601 N. Murlen, Suite 16
Olathe,  KS  66062
Applicant Contact RAY B SMITH
Correspondent
Neurotek, Inc.
601 N. Murlen, Suite 16
Olathe,  KS  66062
Correspondent Contact RAY B SMITH
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received06/09/1989
Decision Date 09/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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