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FDA 510(k)

Frozen N

K-Number: K193665 · 2020-05-28

ApplicantYozma Bmtech Co., Ltd.
Decision Date2020-05-28
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Frozen N is a medical device manufactured by Yozma Bmtech Co., Ltd.. It received FDA 510(k) clearance on 2020-05-28 under approval number K193665. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Frozen N?

Frozen N is a medical device that received FDA 510(k) clearance on 2020-05-28. It is manufactured by Yozma Bmtech Co., Ltd.. The 510(k) number is K193665.

When was Frozen N approved by the FDA?

Frozen N received FDA 510(k) clearance on 2020-05-28, under approval number K193665.

What company makes Frozen N?

Frozen N is manufactured by Yozma Bmtech Co., Ltd..

What is the FDA product code for Frozen N?

The FDA product code for Frozen N is GEH.

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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.

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