FDA 510(k)

TR-100

K 號：K161551 · 2016-09-13

決定日期2016-09-13

產品代碼PBX

諮詢委員會SU

決定Substantially Equivalent

器材摘要

TR-100 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 2016-09-13 under 510(k) number K161551. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TR-100?

TR-100 is a medical device that received FDA 510(k) clearance on 2016-09-13. The listed applicant is BTL Industries, Inc.. The 510(k) number is K161551.

When did TR-100 receive FDA 510(k) clearance?

TR-100 received FDA 510(k) clearance on 2016-09-13, under 510(k) number K161551.

Who is the listed applicant for TR-100?

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 TR-100?

The FDA product code for TR-100 is PBX.

其他以 BTL Industries, Inc. 為申請人之記錄

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相關器械（代碼：PBX）

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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