Nalu Neurostimulation System

Stimulator, Spinal-cord, Implanted (pain Relief)

Nalu Medical, Inc.

The following data is part of a premarket notification filed by Nalu Medical, Inc. with the FDA for Nalu Neurostimulation System.

Pre-market Notification Details

Device IDK203547
510k NumberK203547
Device Name:Nalu Neurostimulation System
ClassificationStimulator, Spinal-cord, Implanted (pain Relief)
Applicant Nalu Medical, Inc. 2320 Faraday Ave. Suite 100 Carlsbad,  CA  92008
ContactPauline Lieu
CorrespondentPauline Lieu
Nalu Medical, Inc. 2320 Faraday Ave. Suite 100 Carlsbad,  CA  92008
Product CodeGZB  
CFR Regulation Number882.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-04
Decision Date2021-03-25

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