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FDA 510(k)

LIFECARE 4100 PCA INFUSER PLUS II

K-Number: K912928 · 1991-08-26

ApplicantAbbott Laboratories
Decision Date1991-08-26
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LIFECARE 4100 PCA INFUSER PLUS II is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1991-08-26 under 510(k) number K912928. 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 LIFECARE 4100 PCA INFUSER PLUS II?

LIFECARE 4100 PCA INFUSER PLUS II is a medical device that received FDA 510(k) clearance on 1991-08-26. The listed applicant is Abbott Laboratories. The 510(k) number is K912928.

When did LIFECARE 4100 PCA INFUSER PLUS II receive FDA 510(k) clearance?

LIFECARE 4100 PCA INFUSER PLUS II received FDA 510(k) clearance on 1991-08-26, under 510(k) number K912928.

Who is the listed applicant for LIFECARE 4100 PCA INFUSER PLUS II?

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 LIFECARE 4100 PCA INFUSER PLUS II?

The FDA product code for LIFECARE 4100 PCA INFUSER PLUS II 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.

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