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FDA 510(k)

Milieve (YPS-301BD)

K-Number: K233751 · 2024-06-03

Decision Date2024-06-03
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Milieve (YPS-301BD) is a medical device manufactured by Soterix Medical, Inc.. It received FDA 510(k) clearance on 2024-06-03 under approval number K233751. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Milieve (YPS-301BD)?

Milieve (YPS-301BD) is a medical device that received FDA 510(k) clearance on 2024-06-03. It is manufactured by Soterix Medical, Inc.. The 510(k) number is K233751.

When was Milieve (YPS-301BD) approved by the FDA?

Milieve (YPS-301BD) received FDA 510(k) clearance on 2024-06-03, under approval number K233751.

What company makes Milieve (YPS-301BD)?

Milieve (YPS-301BD) is manufactured by Soterix Medical, Inc..

What is the FDA product code for Milieve (YPS-301BD)?

The FDA product code for Milieve (YPS-301BD) is PCC.

Other Devices by Soterix Medical, Inc.

Related Devices (Code: PCC)

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.