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FDA 510(k)

INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES

K-Number: K071222 · 2007-05-25

ApplicantBaxter Healthcare Corp
Decision Date2007-05-25
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2007-05-25 under 510(k) number K071222. 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 SV AND LV ELASTOMERIC INFUSION DEVICES?

INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K071222.

When did INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES receive FDA 510(k) clearance?

INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES received FDA 510(k) clearance on 2007-05-25, under 510(k) number K071222.

Who is the listed applicant for INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES?

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

What is the FDA product code for INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES?

The FDA product code for INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES is MEB.

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Other records listing Baxter Healthcare Corp as applicant

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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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