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FDA 510(k)

DISPOSABLE, AMBULATORY, INFUSION PUMPS

K-Number: K940406 · 1994-09-02

ApplicantVlv Associates, Inc.
Decision Date1994-09-02
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

DISPOSABLE, AMBULATORY, INFUSION PUMPS is the device name listed in this FDA 510(k) record. The listed applicant is Vlv Associates, Inc.. It received FDA 510(k) clearance on 1994-09-02 under 510(k) number K940406. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the DISPOSABLE, AMBULATORY, INFUSION PUMPS?

DISPOSABLE, AMBULATORY, INFUSION PUMPS is a medical device that received FDA 510(k) clearance on 1994-09-02. The listed applicant is Vlv Associates, Inc.. The 510(k) number is K940406.

When did DISPOSABLE, AMBULATORY, INFUSION PUMPS receive FDA 510(k) clearance?

DISPOSABLE, AMBULATORY, INFUSION PUMPS received FDA 510(k) clearance on 1994-09-02, under 510(k) number K940406.

Who is the listed applicant for DISPOSABLE, AMBULATORY, INFUSION PUMPS?

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

What is the FDA product code for DISPOSABLE, AMBULATORY, INFUSION PUMPS?

The FDA product code for DISPOSABLE, AMBULATORY, INFUSION PUMPS is MEB.

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Other records listing Vlv Associates, Inc. as applicant

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K972957SA-EF MULTI-LUMEN EXTENSION SETK964876SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SETK955783VLV SA.EF INFUSION PORT EXTENSION SETSK953791VLV SA EF INFUSION PORTK945592VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGEK933364PROMED BIOPSY NEEDLE

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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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