FDA 510(k)

VERIFY ASSERT STEAM Process Challenge Device

K-Number: K162945 · 2017-04-28

Decision Date2017-04-28

Product CodeOWP

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VERIFY ASSERT STEAM Process Challenge Device is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K162945. The device is classified under product code OWP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERIFY ASSERT STEAM Process Challenge Device?

VERIFY ASSERT STEAM Process Challenge Device is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is STERIS Corporation. The 510(k) number is K162945.

When did VERIFY ASSERT STEAM Process Challenge Device receive FDA 510(k) clearance?

VERIFY ASSERT STEAM Process Challenge Device received FDA 510(k) clearance on 2017-04-28, under 510(k) number K162945.

Who is the listed applicant for VERIFY ASSERT STEAM Process Challenge Device?

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 VERIFY ASSERT STEAM Process Challenge Device?

The FDA product code for VERIFY ASSERT STEAM Process Challenge Device is OWP.

Other records listing STERIS Corporation as applicant

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Related Devices (Code: OWP)

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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.