FDA 510(k)

SporView 빠른 읽기 생물학적 지표

K-번호: K172432 · 2017-12-12

신청자Crosstex/Spsmedical, A Division of Cantel Medical

결정일2017-12-12

제품 코드FRC

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

결정대체적으로 동일

기기 요약

SporView Rapid Read Biological Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Crosstex/Spsmedical, A Division of Cantel Medical. It received FDA 510(k) clearance on 2017-12-12 under 510(k) number K172432. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SporView Rapid Read Biological Indicator?

SporView Rapid Read Biological Indicator is a medical device that received FDA 510(k) clearance on 2017-12-12. The listed applicant is Crosstex/Spsmedical, A Division of Cantel Medical. The 510(k) number is K172432.

When did SporView Rapid Read Biological Indicator receive FDA 510(k) clearance?

SporView Rapid Read Biological Indicator received FDA 510(k) clearance on 2017-12-12, under 510(k) number K172432.

Who is the listed applicant for SporView Rapid Read Biological Indicator?

The FDA 510(k) record lists Crosstex/Spsmedical, A Division of Cantel Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SporView Rapid Read Biological Indicator?

The FDA product code for SporView Rapid Read Biological Indicator is FRC.

Crosstex/Spsmedical, A Division of Cantel Medical를 신청인으로 등재한 기타 기록

K181434SporView Rapid Read 생물학적 지표 스팀플러스 테스트 팩

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