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FDA 510(k)

OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP

K-Number: K982256 · 1998-09-30

ApplicantMckinley, Inc.
Decision Date1998-09-30
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Mckinley, Inc.. It received FDA 510(k) clearance on 1998-09-30 under 510(k) number K982256. 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 OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP?

OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is Mckinley, Inc.. The 510(k) number is K982256.

When did OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP receive FDA 510(k) clearance?

OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP received FDA 510(k) clearance on 1998-09-30, under 510(k) number K982256.

Who is the listed applicant for OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP?

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 OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP?

The FDA product code for OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP 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, PCAK033039MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITSK032642BEELINE SYSTEMK991275WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUSK990461MCKINLEY SP DISPOSABLE INFUSION 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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