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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 K060158
Device Name NET-2000 MICROCURRENT STIMULATOR
Applicant
Auri-Stem Medical Inc.
4655 Kirkwood Court
Boulder,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
Auri-Stim Medical Inc.
4655 Kirkwood Court
Boulder,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received01/20/2006
Decision Date 10/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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