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FDA 510(k)

Purema® H Hemoconcentrator (EtO Sterilized)

K-Number: K232171 · 2024-02-07

ApplicantTecnoideal America
Decision Date2024-02-07
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Purema® H Hemoconcentrator (EtO Sterilized) is a medical device manufactured by Tecnoideal America. It received FDA 510(k) clearance on 2024-02-07 under approval number K232171. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Purema® H Hemoconcentrator (EtO Sterilized)?

Purema® H Hemoconcentrator (EtO Sterilized) is a medical device that received FDA 510(k) clearance on 2024-02-07. It is manufactured by Tecnoideal America. The 510(k) number is K232171.

When was Purema® H Hemoconcentrator (EtO Sterilized) approved by the FDA?

Purema® H Hemoconcentrator (EtO Sterilized) received FDA 510(k) clearance on 2024-02-07, under approval number K232171.

What company makes Purema® H Hemoconcentrator (EtO Sterilized)?

Purema® H Hemoconcentrator (EtO Sterilized) is manufactured by Tecnoideal America.

What is the FDA product code for Purema® H Hemoconcentrator (EtO Sterilized)?

The FDA product code for Purema® H Hemoconcentrator (EtO Sterilized) is KDI.

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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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