FDA 510(k)

MINE ALNU (Model: Mine 2.1)

K-Number: K213405 · 2022-07-10

Decision Date2022-07-10

Product CodeIZL

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MINE ALNU (Model: Mine 2.1) is a medical device manufactured by Hdt Co., Ltd.. It received FDA 510(k) clearance on 2022-07-10 under approval number K213405. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINE ALNU (Model: Mine 2.1)?

MINE ALNU (Model: Mine 2.1) is a medical device that received FDA 510(k) clearance on 2022-07-10. It is manufactured by Hdt Co., Ltd.. The 510(k) number is K213405.

When was MINE ALNU (Model: Mine 2.1) approved by the FDA?

MINE ALNU (Model: Mine 2.1) received FDA 510(k) clearance on 2022-07-10, under approval number K213405.

What company makes MINE ALNU (Model: Mine 2.1)?

MINE ALNU (Model: Mine 2.1) is manufactured by Hdt Co., Ltd..

What is the FDA product code for MINE ALNU (Model: Mine 2.1)?

The FDA product code for MINE ALNU (Model: Mine 2.1) is IZL.

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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.