FDA 510(k)

SAFETY INFUSION SET

K-Number: K121908 · 2012-07-25

ApplicantGreiner Bio-One North America, Inc.

Decision Date2012-07-25

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SAFETY INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One North America, Inc.. It received FDA 510(k) clearance on 2012-07-25 under 510(k) number K121908. 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 SAFETY INFUSION SET?

SAFETY INFUSION SET is a medical device that received FDA 510(k) clearance on 2012-07-25. The listed applicant is Greiner Bio-One North America, Inc.. The 510(k) number is K121908.

When did SAFETY INFUSION SET receive FDA 510(k) clearance?

SAFETY INFUSION SET received FDA 510(k) clearance on 2012-07-25, under 510(k) number K121908.

Who is the listed applicant for SAFETY INFUSION SET?

The FDA 510(k) record lists Greiner Bio-One North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFETY INFUSION SET?

The FDA product code for SAFETY INFUSION SET is FMI.

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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.