FDA 510(k)

EON 이동식 반도체 반복ろ정수 정화 시스템

K-번호: K171099 · 2018-01-05

신청자Cantel

결정일2018-01-05

제품 코드FIP

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

EON Portable Reverse Osmosis Water Purification System is the device name listed in this FDA 510(k) record. The listed applicant is Cantel. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K171099. 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 EON Portable Reverse Osmosis Water Purification System?

EON Portable Reverse Osmosis Water Purification System is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Cantel. The 510(k) number is K171099.

When did EON Portable Reverse Osmosis Water Purification System receive FDA 510(k) clearance?

EON Portable Reverse Osmosis Water Purification System received FDA 510(k) clearance on 2018-01-05, under 510(k) number K171099.

Who is the listed applicant for EON Portable Reverse Osmosis Water Purification System?

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

What is the FDA product code for EON Portable Reverse Osmosis Water Purification System?

The FDA product code for EON Portable Reverse Osmosis Water Purification System is FIP.

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EON 이동식 반도체 반복ろ정수 정화 시스템

기기 요약

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관련 임상시험

관련 기기 (코드: FIP)

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