FDA 510(k)

Persyst 15 腦電圖評估与分析軟體

K 號：K222002 · 2022-12-30

決定日期2022-12-30

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 15 EEG Review and Analysis Software 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 2022-12-30 under 510(k) number K222002. 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 15 EEG Review and Analysis Software?

Persyst 15 EEG Review and Analysis Software is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Persyst Development Corporation. The 510(k) number is K222002.

When did Persyst 15 EEG Review and Analysis Software receive FDA 510(k) clearance?

Persyst 15 EEG Review and Analysis Software received FDA 510(k) clearance on 2022-12-30, under 510(k) number K222002.

Who is the listed applicant for Persyst 15 EEG Review and Analysis Software?

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 15 EEG Review and Analysis Software?

The FDA product code for Persyst 15 EEG Review and Analysis Software 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)）K182181Persyst 14 腦電圖評估与分析軟體 K171184Persyst 行動應用程式

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 K241589Ceribell 癲癇偵測軟體Ceribell, Inc.K243743autoSCORE (V 2.0.0)Holberg Eeg AS K242446Persyst 15 腦電圖評估与分析軟體（Persyst 15 (P15)）Persyst Development Corporation

官方來源

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