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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 K182311
Device Name Cervella
Applicant
Innovative Neurological Devices LLC
13295 Illinois St, Suite 312
Carmel,  IN  46032
Applicant Contact Bart Waclawik
Correspondent
Innovative Neurological Devices LLC
13295 Illinois St, Suite 312
Carmel,  IN  46032
Correspondent Contact Bart Waclawik
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received08/24/2018
Decision Date 03/07/2019
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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