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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Japan Corporation. It received FDA 510(k) clearance on 2024-04-11 under 510(k) 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. The listed applicant is Ge Healthcare Japan Corporation. The 510(k) number is K233698.

When did True Enhance DL receive FDA 510(k) clearance?

True Enhance DL received FDA 510(k) clearance on 2024-04-11, under 510(k) number K233698.

Who is the listed applicant for True Enhance DL?

The FDA 510(k) record lists Ge Healthcare Japan Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for True Enhance DL?

The FDA product code for True Enhance DL is JAK.

Other records listing Ge Healthcare Japan Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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