True Enhance DL
K-Number: K233698 · 2024-04-11
ApplicantGe Healthcare Japan Corporation
Decision Date2024-04-11
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
True Enhance DL is a medical device manufactured by Ge Healthcare Japan Corporation. It received FDA 510(k) clearance on 2024-04-11 under approval number K233698. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the True Enhance DL?
True Enhance DL is a medical device that received FDA 510(k) clearance on 2024-04-11. It is manufactured by Ge Healthcare Japan Corporation. The 510(k) number is K233698.
When was True Enhance DL approved by the FDA?
True Enhance DL received FDA 510(k) clearance on 2024-04-11, under approval number K233698.
What company makes True Enhance DL?
True Enhance DL is manufactured by Ge Healthcare Japan Corporation.
What is the FDA product code for True Enhance DL?
The FDA product code for True Enhance DL is JAK.
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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.