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FDA 510(k)

馬哈納並行數位認知行為治療(CBT)手機應用程序,用於治療憤怒腸道综合症(IBS)

K 號:K211372 · 2021-06-02

決定日期2021-06-02
產品代碼QMY
諮詢委員會GU
決定相當於

器材摘要

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) is the device name listed in this FDA 510(k) record. The listed applicant is Mahana Therapeutics, Inc.. It received FDA 510(k) clearance on 2021-06-02 under 510(k) number K211372. The device is classified under product code QMY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)?

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is Mahana Therapeutics, Inc.. The 510(k) number is K211372.

When did Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) receive FDA 510(k) clearance?

Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) received FDA 510(k) clearance on 2021-06-02, under 510(k) number K211372.

Who is the listed applicant for Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)?

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

What is the FDA product code for Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)?

The FDA product code for Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) is QMY.

相關臨床試驗

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相關器械(代碼:QMY)

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

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