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FDA 510(k)

SYMBIQ INFUSION AND ADMINSTRATION SET

K-Number: K110901 · 2012-03-05

ApplicantHospira, Inc.
Decision Date2012-03-05
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYMBIQ INFUSION AND ADMINSTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Hospira, Inc.. It received FDA 510(k) clearance on 2012-03-05 under 510(k) number K110901. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYMBIQ INFUSION AND ADMINSTRATION SET?

SYMBIQ INFUSION AND ADMINSTRATION SET is a medical device that received FDA 510(k) clearance on 2012-03-05. The listed applicant is Hospira, Inc.. The 510(k) number is K110901.

When did SYMBIQ INFUSION AND ADMINSTRATION SET receive FDA 510(k) clearance?

SYMBIQ INFUSION AND ADMINSTRATION SET received FDA 510(k) clearance on 2012-03-05, under 510(k) number K110901.

Who is the listed applicant for SYMBIQ INFUSION AND ADMINSTRATION SET?

The FDA 510(k) record lists Hospira, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYMBIQ INFUSION AND ADMINSTRATION SET?

The FDA product code for SYMBIQ INFUSION AND ADMINSTRATION SET is FRN.

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Other records listing Hospira, Inc. as applicant

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K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleK161036Hospira Extension Set, Hospira Primary SetK160492Hospira Sapphire SetsK160870Hospira Administration SetsK143612LifeCare PCA Infusion SystemK132276STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML

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Related Devices (Code: FRN)

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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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