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FDA 510(k)

ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP

K-Number: K081905 · 2008-07-15

ApplicantWestmed, Inc.
Decision Date2008-07-15
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Westmed, Inc.. It received FDA 510(k) clearance on 2008-07-15 under 510(k) number K081905. 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 ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP?

ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP is a medical device that received FDA 510(k) clearance on 2008-07-15. The listed applicant is Westmed, Inc.. The 510(k) number is K081905.

When did ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP receive FDA 510(k) clearance?

ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP received FDA 510(k) clearance on 2008-07-15, under 510(k) number K081905.

Who is the listed applicant for ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP?

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

What is the FDA product code for ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP?

The FDA product code for ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP is MEB.

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Other records listing Westmed, Inc. 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.

K162343Westmed Gas Sampling Cannula with O2 deliveryK121382WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]K072220PEDI CO2 EASYK070128CO2 EASYK953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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