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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K173868
Device Name Serenity Body Position Sensor, Serenity RIP Sensors
Applicant
Neurotronics, Inc.
4500 NW 27th Ave. Suite C2
Gainesville,  FL  32606
Applicant Contact David Pezet
Correspondent
Neurotronics, Inc.
4500 NW 27th Ave. Suite C2
Gainesville,  FL  32606
Correspondent Contact David Pezet
Regulation Number882.1400
Classification Product Code
OLV  
Date Received12/20/2017
Decision Date 07/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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