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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical Incorporated. It received FDA 510(k) clearance on 2025-07-08 under 510(k) 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. The listed applicant is Jeisys Medical Incorporated. The 510(k) number is K250065.

When did DENSITY; DENZA; DENSITY Noir receive FDA 510(k) clearance?

DENSITY; DENZA; DENSITY Noir received FDA 510(k) clearance on 2025-07-08, under 510(k) number K250065.

Who is the listed applicant for DENSITY; DENZA; DENSITY Noir?

The FDA 510(k) record lists Jeisys Medical Incorporated as the applicant. This does not by itself establish the device manufacturer.

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.

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