FDA 510(k)

ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384

K-Number: K022203 · 2002-08-01

Decision Date2002-08-01

Product CodeMEA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2002-08-01 under 510(k) number K022203. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384?

ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 is a medical device that received FDA 510(k) clearance on 2002-08-01. The listed applicant is Abbott Laboratories. The 510(k) number is K022203.

When did ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 receive FDA 510(k) clearance?

ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 received FDA 510(k) clearance on 2002-08-01, under 510(k) number K022203.

Who is the listed applicant for ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384?

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

What is the FDA product code for ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384?

The FDA product code for ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 is MEA.

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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.