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FDA 510(k)

RedDrop ONE (One)

K-Number: K234081 · 2024-03-21

ApplicantReddrop DX
Decision Date2024-03-21
Product CodeFMK
Advisory CommitteeSU
DecisionUnknown

Device Summary

RedDrop ONE (One) is a medical device manufactured by Reddrop DX. It received FDA 510(k) clearance on 2024-03-21 under approval number K234081. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the RedDrop ONE (One)?

RedDrop ONE (One) is a medical device that received FDA 510(k) clearance on 2024-03-21. It is manufactured by Reddrop DX. The 510(k) number is K234081.

When was RedDrop ONE (One) approved by the FDA?

RedDrop ONE (One) received FDA 510(k) clearance on 2024-03-21, under approval number K234081.

What company makes RedDrop ONE (One)?

RedDrop ONE (One) is manufactured by Reddrop DX.

What is the FDA product code for RedDrop ONE (One)?

The FDA product code for RedDrop ONE (One) is FMK.

Related Devices (Code: FMK)

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.