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FDA 510(k)

THE SIMPLICITY PUMP #2100 INFUSION PUMP

K-Number: K801546 · 1980-08-27

ApplicantCritikon Company, LLC
Decision Date1980-08-27
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE SIMPLICITY PUMP #2100 INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1980-08-27 under 510(k) number K801546. 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 THE SIMPLICITY PUMP #2100 INFUSION PUMP?

THE SIMPLICITY PUMP #2100 INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1980-08-27. The listed applicant is Critikon Company, LLC. The 510(k) number is K801546.

When did THE SIMPLICITY PUMP #2100 INFUSION PUMP receive FDA 510(k) clearance?

THE SIMPLICITY PUMP #2100 INFUSION PUMP received FDA 510(k) clearance on 1980-08-27, under 510(k) number K801546.

Who is the listed applicant for THE SIMPLICITY PUMP #2100 INFUSION PUMP?

The FDA 510(k) record lists Critikon Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE SIMPLICITY PUMP #2100 INFUSION PUMP?

The FDA product code for THE SIMPLICITY PUMP #2100 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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