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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automatic event detection software for polysomnograph with electroencephalograph
510(k) Number K062943
Device Name POLYSMITH SLEEP SYSTEM, MODEL NTI5498
Applicant
NEUROTRONICS, INC.
102 N.E. 10TH AVE., SUITE 5
GAINESVILLE,  FL  32601
Applicant Contact JENNIFER LAINE
Correspondent
NEUROTRONICS, INC.
102 N.E. 10TH AVE., SUITE 5
GAINESVILLE,  FL  32601
Correspondent Contact JENNIFER LAINE
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Codes
DQA   OLV  
Date Received09/28/2006
Decision Date 05/09/2007
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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