Quantium
K-Number: K242816 · 2024-12-17
ApplicantBisco, Inc.
Decision Date2024-12-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Quantium is a medical device manufactured by Bisco, Inc.. It received FDA 510(k) clearance on 2024-12-17 under approval number K242816. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Quantium?
Quantium is a medical device that received FDA 510(k) clearance on 2024-12-17. It is manufactured by Bisco, Inc.. The 510(k) number is K242816.
When was Quantium approved by the FDA?
Quantium received FDA 510(k) clearance on 2024-12-17, under approval number K242816.
What company makes Quantium?
Quantium is manufactured by Bisco, Inc..
What is the FDA product code for Quantium?
The FDA product code for Quantium is EBF.
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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.