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FDA 510(k)

OCD MT Cap (85-00397-000)

K-Number: K231350 · 2023-06-08

ApplicantNeuronetics
Decision Date2023-06-08
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OCD MT Cap (85-00397-000) is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K231350. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCD MT Cap (85-00397-000)?

OCD MT Cap (85-00397-000) is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Neuronetics. The 510(k) number is K231350.

When did OCD MT Cap (85-00397-000) receive FDA 510(k) clearance?

OCD MT Cap (85-00397-000) received FDA 510(k) clearance on 2023-06-08, under 510(k) number K231350.

Who is the listed applicant for OCD MT Cap (85-00397-000)?

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

What is the FDA product code for OCD MT Cap (85-00397-000)?

The FDA product code for OCD MT Cap (85-00397-000) is QCI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06429748Symptom Evaluation Following Repetitive Transcranial Magnetic StimulationACTIVE_NOT_RECRUITINGNCT07147218Accelerated TMS for MDDACTIVE_NOT_RECRUITING

Other records listing Neuronetics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231926NeuroStar Advanced Therapy System (All previously cleared models)K233621NeuroStar Advanced Therapy System (Version 3.8)K230029NeuroStar Advanced Therapy System (Version 3.7)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 HealthK212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar

View all 11 devices →

Related Devices (Code: QCI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260402MeRT SystemWave NeuroscienceK243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.K230657BTL-99-OCBTL Industries, Inc.K233742CloudTMS Edge for OCDTeleemg, LLCK221129CloudTMS for OCDTeleemg, LLCK212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStarNeuronetics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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