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FDA 510(k)

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation

K-Number: K210605 · 2021-04-29

Applicant3M Company
Decision Date2021-04-29
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation is a medical device manufactured by 3M Company. It received FDA 510(k) clearance on 2021-04-29 under approval number K210605. 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 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation?

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation is a medical device that received FDA 510(k) clearance on 2021-04-29. It is manufactured by 3M Company. The 510(k) number is K210605.

When was 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation approved by the FDA?

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation received FDA 510(k) clearance on 2021-04-29, under approval number K210605.

What company makes 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation?

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation is manufactured by 3M Company.

What is the FDA product code for 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation?

The FDA product code for 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation is DWJ.

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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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