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FDA 510(k)

INTERMATE XLV ELASTOMERIC INFUSION SYSTEM

K-Number: K943664 · 1994-11-03

ApplicantBaxter Healthcare Corp
Decision Date1994-11-03
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INTERMATE XLV ELASTOMERIC INFUSION SYSTEM 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 1994-11-03 under 510(k) number K943664. 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 INTERMATE XLV ELASTOMERIC INFUSION SYSTEM?

INTERMATE XLV ELASTOMERIC INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-11-03. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K943664.

When did INTERMATE XLV ELASTOMERIC INFUSION SYSTEM receive FDA 510(k) clearance?

INTERMATE XLV ELASTOMERIC INFUSION SYSTEM received FDA 510(k) clearance on 1994-11-03, under 510(k) number K943664.

Who is the listed applicant for INTERMATE XLV ELASTOMERIC INFUSION SYSTEM?

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 INTERMATE XLV ELASTOMERIC INFUSION SYSTEM?

The FDA product code for INTERMATE XLV ELASTOMERIC INFUSION SYSTEM 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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