FDA 510(k)

オムニトムエリート

K番号: K211711 · 2022-02-25

申請者Neurologica Corporation, A Subsidiary of Samsung Electronics

決定日2022-02-25

製品コードJAK

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

OmniTom Elite is the device name listed in this FDA 510(k) record. The listed applicant is Neurologica Corporation, A Subsidiary of Samsung Electronics. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K211711. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the OmniTom Elite?

OmniTom Elite is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Neurologica Corporation, A Subsidiary of Samsung Electronics. The 510(k) number is K211711.

When did OmniTom Elite receive FDA 510(k) clearance?

OmniTom Elite received FDA 510(k) clearance on 2022-02-25, under 510(k) number K211711.

Who is the listed applicant for OmniTom Elite?

The FDA 510(k) record lists Neurologica Corporation, A Subsidiary of Samsung Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OmniTom Elite?

The FDA product code for OmniTom Elite is JAK.

申請者としてNeurologica Corporation, A Subsidiary of Samsung Electronicsを記載するその他の記録

K202526オムニトムエリート K172539CereTom エリート K170238ボディトムエリート

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。