FDA 510(k)

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K-번호: K161844 · 2016-12-13

결정일2016-12-13

제품 코드FIP

자문 위원회규제 정책: medical-regulatory-v1 GU

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기기 요약

Matrix Pre-Treatment Controller is the device name listed in this FDA 510(k) record. The listed applicant is Better Water, LLC. It received FDA 510(k) clearance on 2016-12-13 under 510(k) number K161844. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Matrix Pre-Treatment Controller?

Matrix Pre-Treatment Controller is a medical device that received FDA 510(k) clearance on 2016-12-13. The listed applicant is Better Water, LLC. The 510(k) number is K161844.

When did Matrix Pre-Treatment Controller receive FDA 510(k) clearance?

Matrix Pre-Treatment Controller received FDA 510(k) clearance on 2016-12-13, under 510(k) number K161844.

Who is the listed applicant for Matrix Pre-Treatment Controller?

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

What is the FDA product code for Matrix Pre-Treatment Controller?

The FDA product code for Matrix Pre-Treatment Controller is FIP.

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관련 임상시험

관련 기기 (코드: FIP)

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