FDA 510(k)

SYSTEM 1E Liquid Chemical Sterilant Processing System

K号: K161683 · 2016-08-05

决定日期2016-08-05

产品代码MED

咨询委员会HO

决定Substantially Equivalent

器械摘要

SYSTEM 1E Liquid Chemical Sterilant Processing System is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2016-08-05 under 510(k) number K161683. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SYSTEM 1E Liquid Chemical Sterilant Processing System?

SYSTEM 1E Liquid Chemical Sterilant Processing System is a medical device that received FDA 510(k) clearance on 2016-08-05. The listed applicant is STERIS Corporation. The 510(k) number is K161683.

When did SYSTEM 1E Liquid Chemical Sterilant Processing System receive FDA 510(k) clearance?

SYSTEM 1E Liquid Chemical Sterilant Processing System received FDA 510(k) clearance on 2016-08-05, under 510(k) number K161683.

Who is the listed applicant for SYSTEM 1E Liquid Chemical Sterilant Processing System?

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

What is the FDA product code for SYSTEM 1E Liquid Chemical Sterilant Processing System?

The FDA product code for SYSTEM 1E Liquid Chemical Sterilant Processing System is MED.

列明STERIS Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261055AMSCO 700 Steam Sterilizer K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 K260766Celerity 5 HP Biological Indicator (LCB052)K252680Celerity™ 20 HP Biological Indicator K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 K243876VERIFY STEAM Integrating Indicator

查看所有 120 个设备 →

相关器械（代码：MED）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。