FDA 510(k)

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide

K-번호: K203223 · 2021-01-28

신청자Steris

결정일2021-01-28

제품 코드NZA

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2021-01-28 under 510(k) number K203223. The device is classified under product code NZA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide?

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Steris. The 510(k) number is K203223.

When did Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide receive FDA 510(k) clearance?

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide received FDA 510(k) clearance on 2021-01-28, under 510(k) number K203223.

Who is the listed applicant for Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide?

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

What is the FDA product code for Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide?

The FDA product code for Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide is NZA.

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