FDA 510(k)

MindMotionPRO

K 號：K162748 · 2017-04-24

決定日期2017-04-24

產品代碼LXJ

諮詢委員會PM

決定相當於

器材摘要

MindMotionPRO is the device name listed in this FDA 510(k) record. The listed applicant is Mindmaze SA. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K162748. 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 MindMotionPRO?

MindMotionPRO is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is Mindmaze SA. The 510(k) number is K162748.

When did MindMotionPRO receive FDA 510(k) clearance?

MindMotionPRO received FDA 510(k) clearance on 2017-04-24, under 510(k) number K162748.

Who is the listed applicant for MindMotionPRO?

The FDA 510(k) record lists Mindmaze SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MindMotionPRO?

The FDA product code for MindMotionPRO is LXJ.

其他以 Mindmaze SA 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。

K173931MindMotion™ GO

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.K182333VeraReflexion 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.

官方來源

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