FDA 510(k)

HPM-6000

K 號：K160992 · 2016-10-21

決定日期2016-10-21

產品代碼IPF

諮詢委員會PM

決定Substantially Equivalent

器材摘要

HPM-6000 is the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K160992. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HPM-6000?

HPM-6000 is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is BTL Industries, Inc.. The 510(k) number is K160992.

When did HPM-6000 receive FDA 510(k) clearance?

HPM-6000 received FDA 510(k) clearance on 2016-10-21, under 510(k) number K160992.

Who is the listed applicant for HPM-6000?

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

What is the FDA product code for HPM-6000?

The FDA product code for HPM-6000 is IPF.

其他以 BTL Industries, Inc. 為申請人之記錄

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相關器械（代碼：IPF）

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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