FDA 510(k)

NeuroStar Advanced Therapy System (All previously cleared models)

Numéro K : K231926 · 2024-03-22

Date de décision2024-03-22

Code produitOBP

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

NeuroStar Advanced Therapy System (All previously cleared models) is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics, Inc.. It received FDA 510(k) clearance on 2024-03-22 under 510(k) number K231926. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the NeuroStar Advanced Therapy System (All previously cleared models)?

NeuroStar Advanced Therapy System (All previously cleared models) is a medical device that received FDA 510(k) clearance on 2024-03-22. The listed applicant is Neuronetics, Inc.. The 510(k) number is K231926.

When did NeuroStar Advanced Therapy System (All previously cleared models) receive FDA 510(k) clearance?

NeuroStar Advanced Therapy System (All previously cleared models) received FDA 510(k) clearance on 2024-03-22, under 510(k) number K231926.

Who is the listed applicant for NeuroStar Advanced Therapy System (All previously cleared models)?

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 System (All previously cleared models)?

The FDA product code for NeuroStar Advanced Therapy System (All previously cleared models) is OBP.

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Autres dossiers indiquant Neuronetics, Inc. en tant que demandeur

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Dispositifs connexes (Code : OBP)

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Source officielle

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