FDA 510(k)

WHILL 模型 F

K 號：K221438 · 2022-06-07

決定日期2022-06-07

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

WHILL Model F is the device name listed in this FDA 510(k) record. The listed applicant is Whill, Inc.. It received FDA 510(k) clearance on 2022-06-07 under 510(k) number K221438. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WHILL Model F?

WHILL Model F is a medical device that received FDA 510(k) clearance on 2022-06-07. The listed applicant is Whill, Inc.. The 510(k) number is K221438.

When did WHILL Model F receive FDA 510(k) clearance?

WHILL Model F received FDA 510(k) clearance on 2022-06-07, under 510(k) number K221438.

Who is the listed applicant for WHILL Model F?

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

What is the FDA product code for WHILL Model F?

The FDA product code for WHILL Model F is ITI.

其他以 Whill, 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。

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相關器械（代碼：ITI）

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。

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官方來源

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