DENSITY; DENZA; DENSITY Noir
K-Number: K250065 · 2025-07-08
ApplicantJeisys Medical Incorporated
Decision Date2025-07-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DENSITY; DENZA; DENSITY Noir is a medical device manufactured by Jeisys Medical Incorporated. It received FDA 510(k) clearance on 2025-07-08 under approval number K250065. 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; DENZA; DENSITY Noir?
DENSITY; DENZA; DENSITY Noir is a medical device that received FDA 510(k) clearance on 2025-07-08. It is manufactured by Jeisys Medical Incorporated. The 510(k) number is K250065.
When was DENSITY; DENZA; DENSITY Noir approved by the FDA?
DENSITY; DENZA; DENSITY Noir received FDA 510(k) clearance on 2025-07-08, under approval number K250065.
What company makes DENSITY; DENZA; DENSITY Noir?
DENSITY; DENZA; DENSITY Noir is manufactured by Jeisys Medical Incorporated.
What is the FDA product code for DENSITY; DENZA; DENSITY Noir?
The FDA product code for DENSITY; DENZA; DENSITY Noir 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.