FDA 510(k)

Livi Device

K-번호: K252005 · 2026-03-20

결정일2026-03-20

제품 코드HEB

자문 위원회OB

결정Substantially Equivalent

기기 요약

Livi Device is the device name listed in this FDA 510(k) record. The listed applicant is Liviwell, Inc.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K252005. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Livi Device?

Livi Device is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Liviwell, Inc.. The 510(k) number is K252005.

When did Livi Device receive FDA 510(k) clearance?

Livi Device received FDA 510(k) clearance on 2026-03-20, under 510(k) number K252005.

Who is the listed applicant for Livi Device?

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

What is the FDA product code for Livi Device?

The FDA product code for Livi Device is HEB.

관련 기기 (코드: HEB)

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관련 임상시험

관련 기기 (코드: HEB)

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