FDA 510(k)

AssureTech Panel Dip Test, AssureTech Quick Cup Test

Número K: K170049 · 2017-05-02

RequerenteAssure Tech. (Hangzhou) Co, Ltd.

Data da decisão2017-05-02

Código do produtoNFT

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

AssureTech Panel Dip Test, AssureTech Quick Cup Test is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K170049. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AssureTech Panel Dip Test, AssureTech Quick Cup Test?

AssureTech Panel Dip Test, AssureTech Quick Cup Test is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K170049.

When did AssureTech Panel Dip Test, AssureTech Quick Cup Test receive FDA 510(k) clearance?

AssureTech Panel Dip Test, AssureTech Quick Cup Test received FDA 510(k) clearance on 2017-05-02, under 510(k) number K170049.

Who is the listed applicant for AssureTech Panel Dip Test, AssureTech Quick Cup Test?

The FDA 510(k) record lists Assure Tech. (Hangzhou) Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AssureTech Panel Dip Test, AssureTech Quick Cup Test?

The FDA product code for AssureTech Panel Dip Test, AssureTech Quick Cup Test is NFT.

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