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FDA 510(k)

HI-FLO INFUSION PUMP

K-Number: K934671 · 1994-03-14

ApplicantAbbott Laboratories
Decision Date1994-03-14
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HI-FLO 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 1994-03-14 under 510(k) number K934671. 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 HI-FLO INFUSION PUMP?

HI-FLO INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1994-03-14. The listed applicant is Abbott Laboratories. The 510(k) number is K934671.

When did HI-FLO INFUSION PUMP receive FDA 510(k) clearance?

HI-FLO INFUSION PUMP received FDA 510(k) clearance on 1994-03-14, under 510(k) number K934671.

Who is the listed applicant for HI-FLO 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 HI-FLO INFUSION PUMP?

The FDA product code for HI-FLO INFUSION PUMP is FRN.

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Related Devices (Code: 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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