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FDA 510(k)

ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT

K-Number: K023098 · 2002-12-09

ApplicantMckinley Infuser
Decision Date2002-12-09
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mckinley Infuser. It received FDA 510(k) clearance on 2002-12-09 under 510(k) number K023098. 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 ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT?

ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT is a medical device that received FDA 510(k) clearance on 2002-12-09. The listed applicant is Mckinley Infuser. The 510(k) number is K023098.

When did ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT receive FDA 510(k) clearance?

ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT received FDA 510(k) clearance on 2002-12-09, under 510(k) number K023098.

Who is the listed applicant for ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT?

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

What is the FDA product code for ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT?

The FDA product code for ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT is MEB.

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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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