Polysmith Sleep System, Model NTI7593

Standard Polysomnograph With Electroencephalograph

Neurotronics, Inc.

The following data is part of a premarket notification filed by Neurotronics, Inc. with the FDA for Polysmith Sleep System, Model Nti7593.

Pre-market Notification Details

Device IDK161650
510k NumberK161650
Device Name:Polysmith Sleep System, Model NTI7593
ClassificationStandard Polysomnograph With Electroencephalograph
Applicant Neurotronics, Inc. 3600 NW 43rd Street, STE F1 Gainesville,  FL  32606
ContactDavid Pezet
CorrespondentDavid Pezet
Neurotronics, Inc. 3600 NW 43rd Street, STE F1 Gainesville,  FL  32606
Product CodeOLV  
Subsequent Product CodeDQA
Subsequent Product CodeMLO
Subsequent Product CodeOLZ
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-15
Decision Date2017-01-19
Summary:summary

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