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FDA 510(k)

Celerity HP Incubator

K-Number: K190297 · 2019-05-14

Decision Date2019-05-14
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Celerity HP Incubator is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2019-05-14 under approval number K190297. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celerity HP Incubator?

Celerity HP Incubator is a medical device that received FDA 510(k) clearance on 2019-05-14. It is manufactured by STERIS Corporation. The 510(k) number is K190297.

When was Celerity HP Incubator approved by the FDA?

Celerity HP Incubator received FDA 510(k) clearance on 2019-05-14, under approval number K190297.

What company makes Celerity HP Incubator?

Celerity HP Incubator is manufactured by STERIS Corporation.

What is the FDA product code for Celerity HP Incubator?

The FDA product code for Celerity HP Incubator is FRC.

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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.