FDA 510(k)

Barrier EasyWarm Active Self-Warming Blanket

K-Number: K232508 · 2023-09-15

Decision Date2023-09-15

Product CodeDWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Barrier EasyWarm Active Self-Warming Blanket is a medical device manufactured by Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2023-09-15 under approval number K232508. 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 Barrier EasyWarm Active Self-Warming Blanket?

Barrier EasyWarm Active Self-Warming Blanket is a medical device that received FDA 510(k) clearance on 2023-09-15. It is manufactured by Molnlycke Health Care Us, LLC. The 510(k) number is K232508.

When was Barrier EasyWarm Active Self-Warming Blanket approved by the FDA?

Barrier EasyWarm Active Self-Warming Blanket received FDA 510(k) clearance on 2023-09-15, under approval number K232508.

What company makes Barrier EasyWarm Active Self-Warming Blanket?

Barrier EasyWarm Active Self-Warming Blanket is manufactured by Molnlycke Health Care Us, LLC.

What is the FDA product code for Barrier EasyWarm Active Self-Warming Blanket?

The FDA product code for Barrier EasyWarm Active Self-Warming Blanket is DWJ.

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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.