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FDA 510(k)

Celsi Warmer

K-Number: K242964 · 2025-06-20

ApplicantHadleigh Health Technologies
Decision Date2025-06-20
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Celsi Warmer is the device name listed in this FDA 510(k) record. The listed applicant is Hadleigh Health Technologies. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K242964. 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 Celsi Warmer?

Celsi Warmer is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Hadleigh Health Technologies. The 510(k) number is K242964.

When did Celsi Warmer receive FDA 510(k) clearance?

Celsi Warmer received FDA 510(k) clearance on 2025-06-20, under 510(k) number K242964.

Who is the listed applicant for Celsi Warmer?

The FDA 510(k) record lists Hadleigh Health Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Celsi Warmer?

The FDA product code for Celsi Warmer is DWJ.

Other records listing Hadleigh Health Technologies as applicant

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.

K230298Celsi MonitorK181034Pocket Colposcope System

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.K243942Arctic Sun Stat Temperature Management SystemMedivance, 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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