FDA 510(k)

QF10

K-번호: K261470 · 2026-09-09

결정일2026-09-09

제품 코드NHV

자문 위원회GU

결정Substantially Equivalent

기기 요약

QF10 is the device name listed in this FDA 510(k) record. The listed applicant is E.A.M Benelux B.V. It received FDA 510(k) clearance on 2026-09-09 under 510(k) number K261470. The device is classified under product code NHV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the QF10?

QF10 is a medical device that received FDA 510(k) clearance on 2026-09-09. The listed applicant is E.A.M Benelux B.V. The 510(k) number is K261470.

When did QF10 receive FDA 510(k) clearance?

QF10 received FDA 510(k) clearance on 2026-09-09, under 510(k) number K261470.

Who is the listed applicant for QF10?

The FDA 510(k) record lists E.A.M Benelux B.V as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QF10?

The FDA product code for QF10 is NHV.

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기기 요약

자주 묻는 질문

관련 기기 (코드: NHV)

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