FDA 510(k)

Seaman Pro/Seaman

K-번호: K252228 · 2026-04-09

결정일2026-04-09

제품 코드POV

자문 위원회HE

결정Substantially Equivalent

기기 요약

Seaman Pro/Seaman is the device name listed in this FDA 510(k) record. The listed applicant is Checkcells, Inc.. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K252228. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Seaman Pro/Seaman?

Seaman Pro/Seaman is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is Checkcells, Inc.. The 510(k) number is K252228.

When did Seaman Pro/Seaman receive FDA 510(k) clearance?

Seaman Pro/Seaman received FDA 510(k) clearance on 2026-04-09, under 510(k) number K252228.

Who is the listed applicant for Seaman Pro/Seaman?

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

What is the FDA product code for Seaman Pro/Seaman?

The FDA product code for Seaman Pro/Seaman is POV.

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Seaman Pro/Seaman

기기 요약

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관련 임상시험

관련 기기 (코드: POV)

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