FDA 510(k)

HAMILTON-T1, HAMILTON-C1

K 號：K181216 · 2019-08-02

決定日期2019-08-02

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

HAMILTON-T1, HAMILTON-C1 is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Medical AG. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K181216. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HAMILTON-T1, HAMILTON-C1?

HAMILTON-T1, HAMILTON-C1 is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Hamilton Medical AG. The 510(k) number is K181216.

When did HAMILTON-T1, HAMILTON-C1 receive FDA 510(k) clearance?

HAMILTON-T1, HAMILTON-C1 received FDA 510(k) clearance on 2019-08-02, under 510(k) number K181216.

Who is the listed applicant for HAMILTON-T1, HAMILTON-C1?

The FDA 510(k) record lists Hamilton Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAMILTON-T1, HAMILTON-C1?

The FDA product code for HAMILTON-T1, HAMILTON-C1 is CBK.

其他以 Hamilton Medical AG 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。

K201306漢密爾頓-C3 K201658漢姆頓-C6 K193228漢姆頓-G5 K163283HAMILTON-H900、HAMILTON-BC8010、HAMILTON-BC4010 K161450漢密爾頓-C3 K153046漢密爾頓-MR1

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相關器械（代碼：CBK）

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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