FDA 510(k)

WHILL（WHILL型號C2）

K 號：K261175 · 2026-06-12

決定日期2026-06-12

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

WHILL (WHILL Model C2) is the device name listed in this FDA 510(k) record. The listed applicant is Whill, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K261175. 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 (WHILL Model C2)?

WHILL (WHILL Model C2) is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Whill, Inc.. The 510(k) number is K261175.

When did WHILL (WHILL Model C2) receive FDA 510(k) clearance?

WHILL (WHILL Model C2) received FDA 510(k) clearance on 2026-06-12, under 510(k) number K261175.

Who is the listed applicant for WHILL (WHILL Model C2)?

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 (WHILL Model C2)?

The FDA product code for WHILL (WHILL Model C2) 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。

K242760WHILL 模型 R K221438WHILL 模型 F K213383WHILL 模型 C2 K153543WHILL 模型 M

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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