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FDA 510(k)

Barrier EasyWarm Active Self-Warming Blanket

K-Number: K232508 · 2023-09-15

ApplicantMolnlycke Health Care Us, LLC
Decision Date2023-09-15
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Barrier EasyWarm Active Self-Warming Blanket is the device name listed in this FDA 510(k) record. The listed applicant is Molnlycke Health Care Us, LLC. It received FDA 510(k) clearance on 2023-09-15 under 510(k) 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. The listed applicant is Molnlycke Health Care Us, LLC. The 510(k) number is K232508.

When did Barrier EasyWarm Active Self-Warming Blanket receive FDA 510(k) clearance?

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

Who is the listed applicant for Barrier EasyWarm Active Self-Warming Blanket?

The FDA 510(k) record lists Molnlycke Health Care Us, LLC as the applicant. This does not by itself establish the device manufacturer.

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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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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