MINE
K-Number: K180671 · 2019-06-05
ApplicantRht Co., Ltd.
Decision Date2019-06-05
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
MINE is the device name listed in this FDA 510(k) record. The listed applicant is Rht Co., Ltd.. It received FDA 510(k) clearance on 2019-06-05 under 510(k) 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. The listed applicant is Rht Co., Ltd.. The 510(k) number is K180671.
When did MINE receive FDA 510(k) clearance?
MINE received FDA 510(k) clearance on 2019-06-05, under 510(k) number K180671.
Who is the listed applicant for MINE?
The FDA 510(k) record lists Rht Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MINE?
The FDA product code for MINE is EHD.
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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.