Autokeeper — 510(k) da FDA K172095

Resumo do dispositivo

Autokeeper is the device name listed in this FDA 510(k) record. The listed applicant is Medexel Co.,Ltd. It received FDA 510(k) clearance on 2018-07-24 under 510(k) number K172095. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Autokeeper?

Autokeeper is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Medexel Co.,Ltd. The 510(k) number is K172095.

When did Autokeeper receive FDA 510(k) clearance?

Autokeeper received FDA 510(k) clearance on 2018-07-24, under 510(k) number K172095.

Who is the listed applicant for Autokeeper?

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

What is the FDA product code for Autokeeper?

The FDA product code for Autokeeper is FMI.

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