FDA 510(k)

TRV

K 號：K192652 · 2020-05-27

決定日期2020-05-27

產品代碼LXV

決定相當於

器材摘要

TRV is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics A/S. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K192652. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

常見問題

What is the TRV?

TRV is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Interacoustics A/S. The 510(k) number is K192652.

When did TRV receive FDA 510(k) clearance?

TRV received FDA 510(k) clearance on 2020-05-27, under 510(k) number K192652.

Who is the listed applicant for TRV?

The FDA 510(k) record lists Interacoustics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRV?

The FDA product code for TRV is LXV.

其他以 Interacoustics A/S 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K200529歐里安 K200534視覺眼 K191372萊拉 K173567Sera K163149視覺眼 K162037Eclipse 配合 VEMP

查看所有 7 項裝置 →

相關器械（代碼：LXV）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K220231GyroStimUltrathera Technologies, Inc.K200529歐里安Interacoustics A/S K183661ClearEdge 平衡系統Quadrant Biosciences K190735EQ 平衡Upright Science, Inc.K173669K-D 平衡King-Devick Technologies, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。