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FDA 510(k)

ABBOTT GEMSTAR IV INFUSION PUMP

K-Number: K974778 · 1998-03-17

ApplicantAbbott Laboratories
Decision Date1998-03-17
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ABBOTT GEMSTAR IV INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-03-17 under 510(k) number K974778. 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 ABBOTT GEMSTAR IV INFUSION PUMP?

ABBOTT GEMSTAR IV INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1998-03-17. The listed applicant is Abbott Laboratories. The 510(k) number is K974778.

When did ABBOTT GEMSTAR IV INFUSION PUMP receive FDA 510(k) clearance?

ABBOTT GEMSTAR IV INFUSION PUMP received FDA 510(k) clearance on 1998-03-17, under 510(k) number K974778.

Who is the listed applicant for ABBOTT GEMSTAR IV INFUSION PUMP?

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 GEMSTAR IV INFUSION PUMP?

The FDA product code for ABBOTT GEMSTAR IV INFUSION PUMP 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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