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FDA 510(k)

NOVA Patient Warming System

K-Number: K203085 · 2020-11-12

ApplicantEncompass Group, LLC
Decision Date2020-11-12
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVA Patient Warming System is a medical device manufactured by Encompass Group, LLC. It received FDA 510(k) clearance on 2020-11-12 under approval number K203085. 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 NOVA Patient Warming System?

NOVA Patient Warming System is a medical device that received FDA 510(k) clearance on 2020-11-12. It is manufactured by Encompass Group, LLC. The 510(k) number is K203085.

When was NOVA Patient Warming System approved by the FDA?

NOVA Patient Warming System received FDA 510(k) clearance on 2020-11-12, under approval number K203085.

What company makes NOVA Patient Warming System?

NOVA Patient Warming System is manufactured by Encompass Group, LLC.

What is the FDA product code for NOVA Patient Warming System?

The FDA product code for NOVA 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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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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