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FDA 510(k)

DCX Disposable Cassette (DCX)

K-Number: K243998 · 2025-04-25

ApplicantInstitut Geroges Lopez
Decision Date2025-04-25
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DCX Disposable Cassette (DCX) is a medical device manufactured by Institut Geroges Lopez. It received FDA 510(k) clearance on 2025-04-25 under approval number K243998. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DCX Disposable Cassette (DCX)?

DCX Disposable Cassette (DCX) is a medical device that received FDA 510(k) clearance on 2025-04-25. It is manufactured by Institut Geroges Lopez. The 510(k) number is K243998.

When was DCX Disposable Cassette (DCX) approved by the FDA?

DCX Disposable Cassette (DCX) received FDA 510(k) clearance on 2025-04-25, under approval number K243998.

What company makes DCX Disposable Cassette (DCX)?

DCX Disposable Cassette (DCX) is manufactured by Institut Geroges Lopez.

What is the FDA product code for DCX Disposable Cassette (DCX)?

The FDA product code for DCX Disposable Cassette (DCX) is KDN.

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Official Source

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