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FDA 510(k)

STERIS Patient Warming System

K-Number: K200446 · 2020-06-13

ApplicantSTERIS Corporation
Decision Date2020-06-13
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STERIS Patient Warming 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 2020-06-13 under 510(k) number K200446. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERIS Patient Warming System?

STERIS Patient Warming System is a medical device that received FDA 510(k) clearance on 2020-06-13. The listed applicant is STERIS Corporation. The 510(k) number is K200446.

When did STERIS Patient Warming System receive FDA 510(k) clearance?

STERIS Patient Warming System received FDA 510(k) clearance on 2020-06-13, under 510(k) number K200446.

Who is the listed applicant for STERIS Patient Warming 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 STERIS Patient Warming System?

The FDA product code for STERIS Patient Warming System is DWJ.

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Related Devices (Code: DWJ)

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

View on FDA Database →

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

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