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FDA 510(k)

CMFlexTM

K-Number: K213260 · 2022-12-30

ApplicantDimension Inx Corp.
Decision Date2022-12-30
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CMFlexTM is a medical device manufactured by Dimension Inx Corp.. It received FDA 510(k) clearance on 2022-12-30 under approval number K213260. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMFlexTM?

CMFlexTM is a medical device that received FDA 510(k) clearance on 2022-12-30. It is manufactured by Dimension Inx Corp.. The 510(k) number is K213260.

When was CMFlexTM approved by the FDA?

CMFlexTM received FDA 510(k) clearance on 2022-12-30, under approval number K213260.

What company makes CMFlexTM?

CMFlexTM is manufactured by Dimension Inx Corp..

What is the FDA product code for CMFlexTM?

The FDA product code for CMFlexTM is LYC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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