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FDA 510(k)

ConFirm 20 Minute Incubator

K-Number: K233681 · 2023-12-15

ApplicantSTERIS Corporation
Decision Date2023-12-15
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ConFirm 20 Minute Incubator is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K233681. 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 ConFirm 20 Minute Incubator?

ConFirm 20 Minute Incubator is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is STERIS Corporation. The 510(k) number is K233681.

When did ConFirm 20 Minute Incubator receive FDA 510(k) clearance?

ConFirm 20 Minute Incubator received FDA 510(k) clearance on 2023-12-15, under 510(k) number K233681.

Who is the listed applicant for ConFirm 20 Minute Incubator?

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

What is the FDA product code for ConFirm 20 Minute Incubator?

The FDA product code for ConFirm 20 Minute Incubator is FRC.

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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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