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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 a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2020-06-13 under approval 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. It is manufactured by STERIS Corporation. The 510(k) number is K200446.

When was STERIS Patient Warming System approved by the FDA?

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

What company makes STERIS Patient Warming System?

STERIS Patient Warming System is manufactured by STERIS Corporation.

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 PubMed Literature

PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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Related Devices (Code: DWJ)

K152266Altrix Precision Temperature Management SystemStryker Medical K161602Arctic Sun Temperature Management SystemMedivance, Inc. K1713733M Bair Hugger Model 675 Total Temperature Management System3M Company K171149Altrix Temperature Management WrapsStryker Medical K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) K162679IOB Temperature Management SystemIob Medical, Inc.

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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