FDA 510(k)

FD TENS 2090, FD TENS 2095

K号: K152676 · 2016-01-22

决定日期2016-01-22

产品代码GZJ

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决定实质等同

器械摘要

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.

常见问题

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.

列明Fuji Dynamics , Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K161055富士动态失禁刺激电极，型号富士 – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 K152374LL TENS 160A，LL TENS 160B

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

列明Fuji Dynamics , Ltd.为申报人的其他记录

相关器械（代码：GZJ）

官方来源