FDA 510(k)

凍結된 N

K-번호: K193665 · 2020-05-28

결정일2020-05-28

제품 코드GEH

자문 위원회SU

결정Substantially Equivalent

기기 요약

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

자주 묻는 질문

What is the Frozen N?

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

When did Frozen N receive FDA 510(k) clearance?

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

Who is the listed applicant for Frozen N?

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

What is the FDA product code for Frozen N?

The FDA product code for Frozen N is GEH.

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凍結된 N

기기 요약

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관련 임상시험

관련 기기 (코드: GEH)

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