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FDA 510(k)

MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS

K-Number: K033039 · 2003-10-07

ApplicantMckinley, Inc.
Decision Date2003-10-07
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS is the device name listed in this FDA 510(k) record. The listed applicant is Mckinley, Inc.. It received FDA 510(k) clearance on 2003-10-07 under 510(k) number K033039. 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 MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS?

MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS is a medical device that received FDA 510(k) clearance on 2003-10-07. The listed applicant is Mckinley, Inc.. The 510(k) number is K033039.

When did MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS receive FDA 510(k) clearance?

MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS received FDA 510(k) clearance on 2003-10-07, under 510(k) number K033039.

Who is the listed applicant for MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS?

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

What is the FDA product code for MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS?

The FDA product code for MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS is MEB.

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Other records listing Mckinley, 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.

K042228BEELINE MOTIV, PROPOLIS, PCAK032642BEELINE SYSTEMK991275WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUSK990461MCKINLEY SP DISPOSABLE INFUSION PUMPK982256OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMPK971844MCKINLEY OUTBOUND-2 SYSTEM

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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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