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FDA 510(k)

reSET-O

K 號：K173681 · 2018-12-10

申請人Pear Therapeutics, Inc.
決定日期2018-12-10
產品代碼PWE
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

reSET-O is the device name listed in this FDA 510(k) record. The listed applicant is Pear Therapeutics, Inc.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K173681. The device is classified under product code PWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the reSET-O?

reSET-O is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Pear Therapeutics, Inc.. The 510(k) number is K173681.

When did reSET-O receive FDA 510(k) clearance?

reSET-O received FDA 510(k) clearance on 2018-12-10, under 510(k) number K173681.

Who is the listed applicant for reSET-O?

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

What is the FDA product code for reSET-O?

The FDA product code for reSET-O is PWE.

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其他以 Pear Therapeutics, 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。

K191716某麥斯特

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