FDA 510(k)

Autokeeper

K-Number: K172095 · 2018-07-24

Decision Date2018-07-24

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Autokeeper?

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

When was Autokeeper approved by the FDA?

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

What company makes Autokeeper?

Autokeeper is manufactured by Medexel Co.,Ltd.

What is the FDA product code for Autokeeper?

The FDA product code for Autokeeper is FMI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.