FDA 510(k)

SYSTEM 1.5 STERILE PROCESSING SYSTEM

K-Number: K090036 · 2010-04-05

Decision Date2010-04-05

Product CodeMED

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SYSTEM 1.5 STERILE 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 2010-04-05 under 510(k) number K090036. 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 1.5 STERILE PROCESSING SYSTEM?

SYSTEM 1.5 STERILE PROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-05. The listed applicant is STERIS Corporation. The 510(k) number is K090036.

When did SYSTEM 1.5 STERILE PROCESSING SYSTEM receive FDA 510(k) clearance?

SYSTEM 1.5 STERILE PROCESSING SYSTEM received FDA 510(k) clearance on 2010-04-05, under 510(k) number K090036.

Who is the listed applicant for SYSTEM 1.5 STERILE 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 1.5 STERILE PROCESSING SYSTEM?

The FDA product code for SYSTEM 1.5 STERILE PROCESSING SYSTEM is MED.

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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.