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FDA 510(k)

HAMILTON-H900、HAMILTON-BC8010、HAMILTON-BC4010

K 號：K163283 · 2017-09-20

申請人Hamilton Medical AG
決定日期2017-09-20
產品代碼BTT
諮詢委員會AN
決定相當於

器材摘要

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 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 2017-09-20 under 510(k) number K163283. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Hamilton Medical AG. The 510(k) number is K163283.

When did HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 receive FDA 510(k) clearance?

HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 received FDA 510(k) clearance on 2017-09-20, under 510(k) number K163283.

Who is the listed applicant for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010?

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-H900, HAMILTON-BC8010, HAMILTON-BC4010?

The FDA product code for HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 is BTT.

相關臨床試驗

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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-C3K201658漢姆頓-C6K193228漢姆頓-G5K181216HAMILTON-T1, HAMILTON-C1K161450漢密爾頓-C3K153046漢密爾頓-MR1

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官方來源

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