FDA 510(k)

1Derful HS, 1Derful HT

K-번호: K210884 · 2021-07-27

결정일2021-07-27

제품 코드EIH

자문 위원회DE

결정Substantially Equivalent

기기 요약

1Derful HS, 1Derful HT is the device name listed in this FDA 510(k) record. The listed applicant is 1derful, Inc.. It received FDA 510(k) clearance on 2021-07-27 under 510(k) number K210884. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 1Derful HS, 1Derful HT?

1Derful HS, 1Derful HT is a medical device that received FDA 510(k) clearance on 2021-07-27. The listed applicant is 1derful, Inc.. The 510(k) number is K210884.

When did 1Derful HS, 1Derful HT receive FDA 510(k) clearance?

1Derful HS, 1Derful HT received FDA 510(k) clearance on 2021-07-27, under 510(k) number K210884.

Who is the listed applicant for 1Derful HS, 1Derful HT?

The FDA 510(k) record lists 1derful, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1Derful HS, 1Derful HT?

The FDA product code for 1Derful HS, 1Derful HT is EIH.

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1Derful HS, 1Derful HT

기기 요약

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관련 임상시험

관련 기기 (코드: EIH)

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