FDA.reportPublic FDA data

Neuronetics Inc.

Matched from indexed company URL: Neuronetics-Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30048240123004824012Neuronetics Inc.1N2026-01-013222 Phoenixville Pike Malvern PA US 19355

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
961231024495328K233621NeuroStar Advanced Therapy System (Version 3.8)OBP2023-12-13
961231581843974K231926NeuroStar Advanced Therapy System (All previously cleared models)OBP2024-03-22
961231097756148K231350OCD MT Cap (85-00397-000)QCI2023-06-08
961231926389811K230029NeuroStar Advanced Therapy System (Version 3.7)OBP2023-04-04
961231253990742K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental HealthOBP2022-08-24
961231074742406K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental HealthOBP2021-12-10
961231825695487K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStarQCI2022-05-06
961231608871256K201158NeuroStar Advanced TherapyOBP2020-11-20
961231353253899K161519NeuroStar TMS Therapy SystemOBP2016-09-11
961231066743784K160703NeuroStar TMS Therapy SystemOBP2016-06-10
961231671421271K133408NEUROSTAR TMS THERAPY SYSTEMOBP2014-03-28
961231589036207K130233NEUROSTAR TMS THERAPY SYSTEMOBP2013-04-30
961231565259730K083538NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1OBP2008-12-16
961232028353146DEN070003NEUROSTAR TMS SYSTEMOBP2008-10-07
961231414245467

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OBP122024-03-22
QCI22023-06-08