FDA 510(k)

FD TENS 2090, FD TENS 2095

K 號：K152676 · 2016-01-22

決定日期2016-01-22

產品代碼GZJ

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

FD TENS 2090, FD TENS 2095 is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Dynamics , Ltd.. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152676. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FD TENS 2090, FD TENS 2095?

FD TENS 2090, FD TENS 2095 is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Fuji Dynamics , Ltd.. The 510(k) number is K152676.

When did FD TENS 2090, FD TENS 2095 receive FDA 510(k) clearance?

FD TENS 2090, FD TENS 2095 received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152676.

Who is the listed applicant for FD TENS 2090, FD TENS 2095?

The FDA 510(k) record lists Fuji Dynamics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FD TENS 2090, FD TENS 2095?

The FDA product code for FD TENS 2090, FD TENS 2095 is GZJ.

其他以 Fuji Dynamics , Ltd. 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。

K161055富士動力失禁刺激電極，型號富士 – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 K152374LL TENS 160A, LL TENS 160B

相關器械（代碼：GZJ）

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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