FDA 510(k)

ニューロスターエレクトロデンシブトランスクリナルセラション（TMS）治療システム

K番号: K160703 · 2016-06-10

決定日2016-06-10

製品コードOBP

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

NeuroStar TMS Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics, Inc.. It received FDA 510(k) clearance on 2016-06-10 under 510(k) number K160703. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the NeuroStar TMS Therapy System?

NeuroStar TMS Therapy System is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is Neuronetics, Inc.. The 510(k) number is K160703.

When did NeuroStar TMS Therapy System receive FDA 510(k) clearance?

NeuroStar TMS Therapy System received FDA 510(k) clearance on 2016-06-10, under 510(k) number K160703.

Who is the listed applicant for NeuroStar TMS Therapy System?

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 TMS Therapy System?

The FDA product code for NeuroStar TMS Therapy System is OBP.

申請者としてNeuronetics, Inc.を記載するその他の記録

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