FDA 510(k)

SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES

K-Number: K032147 · 2003-07-25

Decision Date2003-07-25

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Alaris Medical Systems, Inc.. It received FDA 510(k) clearance on 2003-07-25 under 510(k) number K032147. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES?

SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES is a medical device that received FDA 510(k) clearance on 2003-07-25. The listed applicant is Alaris Medical Systems, Inc.. The 510(k) number is K032147.

When did SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES receive FDA 510(k) clearance?

SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES received FDA 510(k) clearance on 2003-07-25, under 510(k) number K032147.

Who is the listed applicant for SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES?

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

What is the FDA product code for SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES?

The FDA product code for SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES is FRN.

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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.