FDA 510(k)

Celsi Monitor

K-Number: K230298 · 2023-08-16

Decision Date2023-08-16

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Celsi Monitor is a medical device manufactured by Hadleigh Health Technologies. It received FDA 510(k) clearance on 2023-08-16 under approval number K230298. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celsi Monitor?

Celsi Monitor is a medical device that received FDA 510(k) clearance on 2023-08-16. It is manufactured by Hadleigh Health Technologies. The 510(k) number is K230298.

When was Celsi Monitor approved by the FDA?

Celsi Monitor received FDA 510(k) clearance on 2023-08-16, under approval number K230298.

What company makes Celsi Monitor?

Celsi Monitor is manufactured by Hadleigh Health Technologies.

What is the FDA product code for Celsi Monitor?

The FDA product code for Celsi Monitor is FLL.

Other Devices by Hadleigh Health Technologies

K242964Celsi Warmer

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.