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FDA 510(k)

MINE ALNU (Model: Mine 2.1)

K-Number: K213405 · 2022-07-10

ApplicantHdt Co., Ltd.
Decision Date2022-07-10
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MINE ALNU (Model: Mine 2.1) is the device name listed in this FDA 510(k) record. The listed applicant is Hdt Co., Ltd.. It received FDA 510(k) clearance on 2022-07-10 under 510(k) 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. The listed applicant is Hdt Co., Ltd.. The 510(k) number is K213405.

When did MINE ALNU (Model: Mine 2.1) receive FDA 510(k) clearance?

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

Who is the listed applicant for MINE ALNU (Model: Mine 2.1)?

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

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.

Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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