FDA 510(k)

Lucid M1 頭部經皮多普勒超聲系統（Lucid M1 系統）配備 2MHz 探頭

K 號：K160442 · 2016-10-21

決定日期2016-10-21

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is the device name listed in this FDA 510(k) record. The listed applicant is Neural Analytics, Inc.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K160442. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Neural Analytics, Inc.. The 510(k) number is K160442.

When did Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers receive FDA 510(k) clearance?

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers received FDA 510(k) clearance on 2016-10-21, under 510(k) number K160442.

Who is the listed applicant for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

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

What is the FDA product code for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers?

The FDA product code for Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers is IYN.

其他以 Neural Analytics, 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。

K180455神經機器人

相關器械（代碼：IYN）

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。

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。