FDA 510(k)

Persyst 行動應用程式

K 號：K171184 · 2017-09-21

決定日期2017-09-21

產品代碼OMB

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

Persyst Mobile App is the device name listed in this FDA 510(k) record. The listed applicant is Persyst Development Corporation. It received FDA 510(k) clearance on 2017-09-21 under 510(k) number K171184. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Persyst Mobile App?

Persyst Mobile App is a medical device that received FDA 510(k) clearance on 2017-09-21. The listed applicant is Persyst Development Corporation. The 510(k) number is K171184.

When did Persyst Mobile App receive FDA 510(k) clearance?

Persyst Mobile App received FDA 510(k) clearance on 2017-09-21, under 510(k) number K171184.

Who is the listed applicant for Persyst Mobile App?

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

What is the FDA product code for Persyst Mobile App?

The FDA product code for Persyst Mobile App is OMB.

其他以 Persyst Development Corporation 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。

K242446Persyst 15 腦電圖評估与分析軟體（Persyst 15 (P15)）K222002Persyst 15 腦電圖評估与分析軟體 K182181Persyst 14 腦電圖評估与分析軟體

相關器械（代碼：OMB）

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。

K260998塞瑞貝爾神經學評估軟體Ceribell, Inc.K252070Ceribell嬰兒癲癇偵測軟體Ceribell, Inc.K252160Persyst 15 腦電圖評估与分析軟體（Persyst 15 (P15)）Persyst Development, LLC K243743autoSCORE (V 2.0.0)Holberg Eeg AS K241589Ceribell 癲癇偵測軟體Ceribell, Inc.K242446Persyst 15 腦電圖評估与分析軟體（Persyst 15 (P15)）Persyst Development Corporation

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