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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 a medical device manufactured by Hadleigh Health Technologies. It received FDA 510(k) clearance on 2025-06-20 under approval 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. It is manufactured by Hadleigh Health Technologies. The 510(k) number is K242964.

When was Celsi Warmer approved by the FDA?

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

What company makes Celsi Warmer?

Celsi Warmer is manufactured by Hadleigh Health Technologies.

What is the FDA product code for Celsi Warmer?

The FDA product code for Celsi Warmer is DWJ.

Other Devices by Hadleigh Health Technologies

K230298Celsi Monitor

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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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