FDA 510(k)

Q-Pad Test System

K-번호: K231465 · 2023-12-06

결정일2023-12-06

제품 코드LCP

자문 위원회HE

결정Substantially Equivalent

기기 요약

Q-Pad Test System is the device name listed in this FDA 510(k) record. The listed applicant is Qurasense. It received FDA 510(k) clearance on 2023-12-06 under 510(k) number K231465. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Q-Pad Test System?

Q-Pad Test System is a medical device that received FDA 510(k) clearance on 2023-12-06. The listed applicant is Qurasense. The 510(k) number is K231465.

When did Q-Pad Test System receive FDA 510(k) clearance?

Q-Pad Test System received FDA 510(k) clearance on 2023-12-06, under 510(k) number K231465.

Who is the listed applicant for Q-Pad Test System?

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

What is the FDA product code for Q-Pad Test System?

The FDA product code for Q-Pad Test System is LCP.

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Q-Pad Test System

기기 요약

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관련 임상시험

관련 기기 (코드: LCP)

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