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 a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2023-12-15 under approval 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. It is manufactured by STERIS Corporation. The 510(k) number is K233681.
When was ConFirm 20 Minute Incubator approved by the FDA?
ConFirm 20 Minute Incubator received FDA 510(k) clearance on 2023-12-15, under approval number K233681.
What company makes ConFirm 20 Minute Incubator?
ConFirm 20 Minute Incubator is manufactured by STERIS Corporation.
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.