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FDA 510(k)

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar

Numéro K : K212289 · 2022-05-06

DemandeurNeuronetics, Inc.
Date de décision2022-05-06
Code produitQCI
Comité consultatifNE
DécisionSubstantially Equivalent

Résumé du dispositif

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics, Inc.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K212289. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Neuronetics, Inc.. The 510(k) number is K212289.

When did NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar receive FDA 510(k) clearance?

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar received FDA 510(k) clearance on 2022-05-06, under 510(k) number K212289.

Who is the listed applicant for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

The FDA 510(k) record lists Neuronetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

The FDA product code for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is QCI.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Autres dossiers indiquant Neuronetics, Inc. en tant que demandeur

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

K231926NeuroStar Advanced Therapy System (All previously cleared models)K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental HealthK220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental HealthK213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental HealthK201158NeuroStar Advanced TherapyK161519NeuroStar TMS Therapy System

Voir tous les 8 dispositifs →

Dispositifs connexes (Code : QCI)

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

K243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.K230657BTL-99-OCBTL Industries, Inc.K233742CloudTMS Edge for OCDTeleemg, LLCK231350OCD MT Cap (85-00397-000)NeuroneticsK221129CloudTMS for OCDTeleemg, LLCK193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S

Source officielle

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