FDA 510(k)

BrainScope TBI（型號：Ahead 400）

K 號：K183241 · 2019-02-19

決定日期2019-02-19

產品代碼PIW

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

BrainScope TBI (Model: Ahead 400) is the device name listed in this FDA 510(k) record. The listed applicant is Brainscope Company, Inc.. It received FDA 510(k) clearance on 2019-02-19 under 510(k) number K183241. The device is classified under product code PIW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BrainScope TBI (Model: Ahead 400)?

BrainScope TBI (Model: Ahead 400) is a medical device that received FDA 510(k) clearance on 2019-02-19. The listed applicant is Brainscope Company, Inc.. The 510(k) number is K183241.

When did BrainScope TBI (Model: Ahead 400) receive FDA 510(k) clearance?

BrainScope TBI (Model: Ahead 400) received FDA 510(k) clearance on 2019-02-19, under 510(k) number K183241.

Who is the listed applicant for BrainScope TBI (Model: Ahead 400)?

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

What is the FDA product code for BrainScope TBI (Model: Ahead 400)?

The FDA product code for BrainScope TBI (Model: Ahead 400) is PIW.

其他以 Brainscope Company, Inc. 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。

K190815腦波儀 TBI K181785修改後的BrainScope One K181179腦波視覺一號 K161068Ahead 300

相關器械（代碼：PIW）

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。

K243426Nurochek-Pro 系統Headsafe Mfg Pty, Ltd.K231914Nurochek-II 系統Headsafe Mfg Pty, Ltd.K190815腦波儀 TBIBrainscope Company, Inc.K181785修改後的BrainScope OneBrainscope Company, Inc.K181179腦波視覺一號Brainscope Company, Inc.K161068Ahead 300Brainscope Company, Inc.

官方來源

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