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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 K181709
Device Name Serenity Piezo Sensor, Serenity Thermocouple Sensor
Applicant
Neurotronics, Inc.
4500 NW 27th Ave Ste C2
Gainesville,  FL  32606
Applicant Contact David Pezet
Correspondent
Neurotronics, Inc.
4500 NW 27th Ave Ste C2
Gainesville,  FL  32606
Correspondent Contact David Pezet
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Codes
DQA   GWL   MNR   OLZ  
Date Received06/28/2018
Decision Date 11/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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