FDA 510(k)

SYSTEM 1E Liquid Chemical Sterilant Processing System

K-Number: K180342 · 2018-04-04

Decision Date2018-04-04

Product CodeMED

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SYSTEM 1E Liquid Chemical Sterilant Processing System is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K180342. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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 2018-04-04. The listed applicant is Steris Corporations. The 510(k) number is K180342.

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 2018-04-04, under 510(k) number K180342.

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

The FDA 510(k) record lists Steris Corporations 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.

Other records listing Steris Corporations as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.