FDA 510(k)

Able Medical Devices Valkyrie 胸部固定システム

K番号: K202889 · 2021-03-02

申請者Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices

決定日2021-03-02

製品コードHRS

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

Able Medical Devices Valkyrie Thoracic Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K202889. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Able Medical Devices Valkyrie Thoracic Fixation System?

Able Medical Devices Valkyrie Thoracic Fixation System is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices. The 510(k) number is K202889.

When did Able Medical Devices Valkyrie Thoracic Fixation System receive FDA 510(k) clearance?

Able Medical Devices Valkyrie Thoracic Fixation System received FDA 510(k) clearance on 2021-03-02, under 510(k) number K202889.

Who is the listed applicant for Able Medical Devices Valkyrie Thoracic Fixation System?

The FDA 510(k) record lists Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Able Medical Devices Valkyrie Thoracic Fixation System?

The FDA product code for Able Medical Devices Valkyrie Thoracic Fixation System is HRS.

申請者としてJm Longyear Manufacturing, LLC D.B.A. Able Medical Devicesを記載するその他の記録

K232515Valkyrie Thoracic Fixation System K211695Valkyrie Thoracic Fixation System

公式ソース

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