FDA 510(k)

Vera

K 號：K182333 · 2019-04-09

決定日期2019-04-09

產品代碼LXJ

諮詢委員會PM

決定相當於

器材摘要

Vera is the device name listed in this FDA 510(k) record. The listed applicant is Reflexion Health, Inc.. It received FDA 510(k) clearance on 2019-04-09 under 510(k) number K182333. The device is classified under product code LXJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vera?

Vera is a medical device that received FDA 510(k) clearance on 2019-04-09. The listed applicant is Reflexion Health, Inc.. The 510(k) number is K182333.

When did Vera receive FDA 510(k) clearance?

Vera received FDA 510(k) clearance on 2019-04-09, under 510(k) number K182333.

Who is the listed applicant for Vera?

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

What is the FDA product code for Vera?

The FDA product code for Vera is LXJ.

其他以 Reflexion Health, Inc. 為申請人之記錄

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K192474VERA

相關器械（代碼：LXJ）

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。

K192474VERAReflexion Health, Inc.K180880DARI醫療設備規範文本翻譯： DARI HealthScientific Analytics, Inc.K171547Qualisys醫學設備規範文本 Qualisys臨床系統Qualisys AB K173931MindMotion™ GOMindmaze SA K172882UINCARE 家用Uincare Corp.K162748MindMotionPROMindmaze SA

官方來源

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