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FDA 510(k)

SteadyTemp

K-Number: K233280 · 2024-06-21

ApplicantSteadysense GmbH
Decision Date2024-06-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SteadyTemp is a medical device manufactured by Steadysense GmbH. It received FDA 510(k) clearance on 2024-06-21 under approval number K233280. 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 SteadyTemp?

SteadyTemp is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Steadysense GmbH. The 510(k) number is K233280.

When was SteadyTemp approved by the FDA?

SteadyTemp received FDA 510(k) clearance on 2024-06-21, under approval number K233280.

What company makes SteadyTemp?

SteadyTemp is manufactured by Steadysense GmbH.

What is the FDA product code for SteadyTemp?

The FDA product code for SteadyTemp is FLL.

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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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