Delta4 Insight
K-Number: K223234 · 2024-01-16
ApplicantScandidos AB
Decision Date2024-01-16
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Delta4 Insight is a medical device manufactured by Scandidos AB. It received FDA 510(k) clearance on 2024-01-16 under approval number K223234. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Delta4 Insight?
Delta4 Insight is a medical device that received FDA 510(k) clearance on 2024-01-16. It is manufactured by Scandidos AB. The 510(k) number is K223234.
When was Delta4 Insight approved by the FDA?
Delta4 Insight received FDA 510(k) clearance on 2024-01-16, under approval number K223234.
What company makes Delta4 Insight?
Delta4 Insight is manufactured by Scandidos AB.
What is the FDA product code for Delta4 Insight?
The FDA product code for Delta4 Insight is IYE.
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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.