FDA 510(k)

Voyager軌跡アレイガイド（V-TAG）

K番号: K180854 · 2018-07-23

決定日2018-07-23

製品コードHAW

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

Voyager Trajectory Array Guide (V-TAG) is the device name listed in this FDA 510(k) record. The listed applicant is Voyager Therapeutics, Inc.. It received FDA 510(k) clearance on 2018-07-23 under 510(k) number K180854. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Voyager Trajectory Array Guide (V-TAG)?

Voyager Trajectory Array Guide (V-TAG) is a medical device that received FDA 510(k) clearance on 2018-07-23. The listed applicant is Voyager Therapeutics, Inc.. The 510(k) number is K180854.

When did Voyager Trajectory Array Guide (V-TAG) receive FDA 510(k) clearance?

Voyager Trajectory Array Guide (V-TAG) received FDA 510(k) clearance on 2018-07-23, under 510(k) number K180854.

Who is the listed applicant for Voyager Trajectory Array Guide (V-TAG)?

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

What is the FDA product code for Voyager Trajectory Array Guide (V-TAG)?

The FDA product code for Voyager Trajectory Array Guide (V-TAG) is HAW.

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Voyager軌跡アレイガイド（V-TAG）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：HAW）

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