FDA 510(k)

ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML

K-Number: K020485 · 2002-03-12

Decision Date2002-03-12

Product CodeKPE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2002-03-12 under 510(k) number K020485. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML?

ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML is a medical device that received FDA 510(k) clearance on 2002-03-12. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K020485.

When did ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML receive FDA 510(k) clearance?

ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML received FDA 510(k) clearance on 2002-03-12, under 510(k) number K020485.

Who is the listed applicant for ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML?

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

What is the FDA product code for ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML?

The FDA product code for ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML is KPE.

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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.