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FDA 510(k)

MINE

K-Number: K180671 · 2019-06-05

ApplicantRht Co., Ltd.
Decision Date2019-06-05
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINE is a medical device manufactured by Rht Co., Ltd.. It received FDA 510(k) clearance on 2019-06-05 under approval number K180671. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINE?

MINE is a medical device that received FDA 510(k) clearance on 2019-06-05. It is manufactured by Rht Co., Ltd.. The 510(k) number is K180671.

When was MINE approved by the FDA?

MINE received FDA 510(k) clearance on 2019-06-05, under approval number K180671.

What company makes MINE?

MINE is manufactured by Rht Co., Ltd..

What is the FDA product code for MINE?

The FDA product code for MINE is EHD.

Related Devices (Code: EHD)

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.