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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 K092699
Device Name NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
Applicant
NEUROTRONICS, INC.
912 NE 2ND ST.
GAINESVILLE,  FL  32601
Applicant Contact JAMES SCHUBERT
Correspondent
NEUROTRONICS, INC.
912 NE 2ND ST.
GAINESVILLE,  FL  32601
Correspondent Contact JAMES SCHUBERT
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Codes
DQA   MNR  
Date Received09/02/2009
Decision Date 03/18/2010
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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