FDA 510(k)

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer

K-번호: K151725 · 2016-01-13

결정일2016-01-13

제품 코드MLR

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정Substantially Equivalent

기기 요약

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K151725. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the STERRAD NX Sterilizer, STERRAD 100NX Sterilizer?

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Advanced Sterilization Products. The 510(k) number is K151725.

When did STERRAD NX Sterilizer, STERRAD 100NX Sterilizer receive FDA 510(k) clearance?

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer received FDA 510(k) clearance on 2016-01-13, under 510(k) number K151725.

Who is the listed applicant for STERRAD NX Sterilizer, STERRAD 100NX Sterilizer?

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

What is the FDA product code for STERRAD NX Sterilizer, STERRAD 100NX Sterilizer?

The FDA product code for STERRAD NX Sterilizer, STERRAD 100NX Sterilizer is MLR.

Advanced Sterilization Products를 신청인으로 등재한 기타 기록

K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator K162007STERRAD NX Sterilizer K160818STERRAD® NX Sterilizer with ALLClear™ Technology K160903STERRAD 100NX Sterilizer with ALLClearTM Technology

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