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FDA 510(k)

INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES

K-Number: K062457 · 2006-09-21

ApplicantBaxter Healthcare Corporation
Decision Date2006-09-21
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2006-09-21 under 510(k) number K062457. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES?

INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES is a medical device that received FDA 510(k) clearance on 2006-09-21. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K062457.

When did INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES receive FDA 510(k) clearance?

INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES received FDA 510(k) clearance on 2006-09-21, under 510(k) number K062457.

Who is the listed applicant for INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES?

The FDA product code for INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES is MEB.

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Other records listing Baxter Healthcare Corporation 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.

K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryK251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)K243529Solution Administration SetsK242339Intravascular Extension Sets and AccessoriesK242390Novum IQ Syringe Pump (40800BAXUS)

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Related Devices (Code: MEB)

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.

K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.K240624InfuLifeFirst Medical Source, LLCK242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.K181360ON-Q* Pump with BolusHalyard HealthK151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.K131247MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEMMfs - Medical Flow Systems, Ltd.

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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