FDA 510(k)

Syzygy稳定系统

K号: K152412 · 2016-04-29

决定日期2016-04-29

产品代码LEJ

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决定实质等同

器械摘要

T-32;T-40;T-44;T-52;T-72;TT-50 is the device name listed in this FDA 510(k) record. The listed applicant is Tanses Technologies, Inc.. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K152412. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the T-32;T-40;T-44;T-52;T-72;TT-50?

T-32;T-40;T-44;T-52;T-72;TT-50 is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Tanses Technologies, Inc.. The 510(k) number is K152412.

When did T-32;T-40;T-44;T-52;T-72;TT-50 receive FDA 510(k) clearance?

T-32;T-40;T-44;T-52;T-72;TT-50 received FDA 510(k) clearance on 2016-04-29, under 510(k) number K152412.

Who is the listed applicant for T-32;T-40;T-44;T-52;T-72;TT-50?

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

What is the FDA product code for T-32;T-40;T-44;T-52;T-72;TT-50?

The FDA product code for T-32;T-40;T-44;T-52;T-72;TT-50 is LEJ.

列明Tanses Technologies, Inc.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。

K180585Collagentex Rx-6 K162022Collagentex Rx-1

相关器械（代码：LEJ）

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。

K221523晒黑灯Unilam Co., Ltd.K220500Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by ErgolineJk-Holding GmbH K191881KBL 7000 alpha hybridSun，KBL 7900 alpha hybridSun，KBL 8000 alpha hybridSunKbl GmbH K190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / SoundJk-Holding GmbH K183539Ergoline Sunrise 7200 Hybrid TechnologyJk-Holding GmbH K180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbH

官方来源

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