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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K220631
Device Name NomadAir PMU810
Applicant
Neurotronics, Inc.
4500 NW 27th Ave. Suite C2
Gainesville,  FL  32606
Applicant Contact James "Cody" Smith
Correspondent
Neurotronics, Inc.
4500 NW 27th Ave. Suite C2
Gainesville,  FL  32606
Correspondent Contact James "Cody" Smith
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Code
MNR  
Date Received03/04/2022
Decision Date 07/15/2022
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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