NomadAir PMU810

Amplifier, Physiological Signal

Neurotronics, Inc.

The following data is part of a premarket notification filed by Neurotronics, Inc. with the FDA for Nomadair Pmu810.

Pre-market Notification Details

Device IDK220631
510k NumberK220631
Device Name:NomadAir PMU810
ClassificationAmplifier, Physiological Signal
Applicant Neurotronics, Inc. 4500 NW 27th Ave STE C2 Gainesville,  FL  32606
ContactJames "Cody" Smith
CorrespondentJames "Cody" Smith
Neurotronics, Inc. 4500 NW 27th Ave STE C2 Gainesville,  FL  32606
Product CodeGWL  
CFR Regulation Number882.1835 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-04
Decision Date2022-07-15

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