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FDA 510(k)

Medline ComfortTemp Patient Warming System

K-Number: K231211 · 2023-12-01

ApplicantMedline Industries, LP
Decision Date2023-12-01
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medline ComfortTemp Patient Warming System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K231211. 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 Medline ComfortTemp Patient Warming System?

Medline ComfortTemp Patient Warming System is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Medline Industries, LP. The 510(k) number is K231211.

When did Medline ComfortTemp Patient Warming System receive FDA 510(k) clearance?

Medline ComfortTemp Patient Warming System received FDA 510(k) clearance on 2023-12-01, under 510(k) number K231211.

Who is the listed applicant for Medline ComfortTemp Patient Warming System?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ComfortTemp Patient Warming System?

The FDA product code for Medline ComfortTemp Patient Warming System 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.

K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.K242964Celsi WarmerHadleigh Health Technologies

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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