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FDA 510(k)

U&U Blood Collection Sets

K-Number: K181508 · 2019-02-13

ApplicantU&U Medical Technology Co, Ltd.
Decision Date2019-02-13
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

U&U Blood Collection Sets is the device name listed in this FDA 510(k) record. The listed applicant is U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2019-02-13 under 510(k) number K181508. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U&U Blood Collection Sets?

U&U Blood Collection Sets is a medical device that received FDA 510(k) clearance on 2019-02-13. The listed applicant is U&U Medical Technology Co, Ltd.. The 510(k) number is K181508.

When did U&U Blood Collection Sets receive FDA 510(k) clearance?

U&U Blood Collection Sets received FDA 510(k) clearance on 2019-02-13, under 510(k) number K181508.

Who is the listed applicant for U&U Blood Collection Sets?

The FDA 510(k) record lists U&U Medical Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U&U Blood Collection Sets?

The FDA product code for U&U Blood Collection Sets is FMI.

Other records listing U&U Medical Technology Co, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FMI)

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Official Source

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