Density
K-Number: K230663 · 2023-08-14
ApplicantJeisys Medical, Inc.
Decision Date2023-08-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Density is a medical device manufactured by Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2023-08-14 under approval number K230663. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Density?
Density is a medical device that received FDA 510(k) clearance on 2023-08-14. It is manufactured by Jeisys Medical, Inc.. The 510(k) number is K230663.
When was Density approved by the FDA?
Density received FDA 510(k) clearance on 2023-08-14, under approval number K230663.
What company makes Density?
Density is manufactured by Jeisys Medical, Inc..
What is the FDA product code for Density?
The FDA product code for Density is GEI.
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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.