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FDA 510(k)

FAgamin®

K-Number: K240059 · 2024-05-16

ApplicantTedequim Srl
Decision Date2024-05-16
Product CodePHR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FAgamin® is a medical device manufactured by Tedequim Srl. It received FDA 510(k) clearance on 2024-05-16 under approval number K240059. The device is classified under product code PHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FAgamin®?

FAgamin® is a medical device that received FDA 510(k) clearance on 2024-05-16. It is manufactured by Tedequim Srl. The 510(k) number is K240059.

When was FAgamin® approved by the FDA?

FAgamin® received FDA 510(k) clearance on 2024-05-16, under approval number K240059.

What company makes FAgamin®?

FAgamin® is manufactured by Tedequim Srl.

What is the FDA product code for FAgamin®?

The FDA product code for FAgamin® is PHR.

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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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