FDA 510(k)

MINE ALNU (Model: Mine 2.1)

Numéro K : K213405 · 2022-07-10

Date de décision2022-07-10

Code produitIZL

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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