FDA 510(k)

Geko™ Plus R-2 神经肌肉刺激器

K号: K160299 · 2016-04-08

决定日期2016-04-08

产品代码IPF

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决定实质等同

器械摘要

geko(TM) Plus R-2 Neuromuscular Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind Limited. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K160299. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the geko(TM) Plus R-2 Neuromuscular Stimulator?

geko(TM) Plus R-2 Neuromuscular Stimulator is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Firstkind Limited. The 510(k) number is K160299.

When did geko(TM) Plus R-2 Neuromuscular Stimulator receive FDA 510(k) clearance?

geko(TM) Plus R-2 Neuromuscular Stimulator received FDA 510(k) clearance on 2016-04-08, under 510(k) number K160299.

Who is the listed applicant for geko(TM) Plus R-2 Neuromuscular Stimulator?

The FDA 510(k) record lists Firstkind Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for geko(TM) Plus R-2 Neuromuscular Stimulator?

The FDA product code for geko(TM) Plus R-2 Neuromuscular Stimulator is IPF.

列明Firstkind Limited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。

K220327geko W-3 K212762geko W-2 K201131萤火虫 T-2 K193045geko™ W-2 K191113geko T-2 和 geko T-3 神经肌肉刺激器 K181059geko T-3 神经肌肉刺激器

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官方来源

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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。