FDA 510(k)

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System

Número K: K173345 · 2018-05-04

Data da decisão2018-05-04

Código do produtoJIN

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K173345. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System?

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K173345.

When did TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System receive FDA 510(k) clearance?

TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System received FDA 510(k) clearance on 2018-05-04, under 510(k) number K173345.

Who is the listed applicant for TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System?

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

What is the FDA product code for TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System?

The FDA product code for TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System is JIN.

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Fonte oficial

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